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Tear film break-up time was measured on 6 consecutive workdays in 6 subjects without eye disease selected at random. The reasons for the wide range of scatter in the values measured were investigated by variance component estimation. It was found that intraindividual variance is by far the most important factor influencing the overall variance of the measured values. Therefore, caution is called for when judging the stability of the precorneal tear film by the tear film break-up time in healthy individuals.

In earlier studies, an irregular tear film could be responsible for artifacts in imaging procedures in ophthalmology. As a result, this study will investigate the influence of hyaluronic acid-containing tear substitutes of different viscosities on the measurement results of optical coherence tomography and on the non-invasive tear film break-up time.The study included three sessions in which three hyaluronic acid tear substitutes of different viscosities (Hylo-Vision 0.1%, 0.2%, 0.3%, OmniVision GmbH, Puchheim, Germany) were applied to each subject. In 20 healthy volunteers, the non-invasive tear film break-up time was measured before and after the application of the tear substitutes using Keratograph 5M (Oculus GmbH, Wetzlar, Germany) and optical coherence tomography using 3D OCT-2000 (Topcon, Hamburg, Germany).The median age of the volunteers was 28.5 years. 11 women (55%) and 9 men (45%) were examined. The non-invasive tear film break-up time improved significantly (p = 0.027) after the application of 0.3% hyaluronic acid. In the study, no significant difference was found in all OCT parameters used before and after application of the different viscous hyaluronic acid-containing tear substitutes.In this study, no influence of tear substitutes containing different viscosities of hyaluronic acid on the measurement results of optical coherence tomography could be determined. Therefore, 0.1%, 0.2% and 0.3% hyaluronic acid can be applied to the patient to improve the corneal surface before the examination with optical coherence tomography, without influencing the measurement results of optical coherence tomography.In früheren Studien konnte ein unregelmäßiger Tränenfilm für Artefakte in den bildgebenden Verfahren in der Augenheilkunde verantwortlich gemacht werden. Infolgedessen soll in dieser Arbeit die Einflussnahme von hyaluronsäurehaltigen Tränenersatzmitteln unterschiedlicher Viskosität auf die Messergebnisse der optischen Kohärenztomografie sowie auf die Tränenfilmaufreißzeit untersucht werden.Die Studie umfasste 3 Sitzungen, in denen den Probanden jeweils 3 hyaluronsäurehaltige Tränenersatzmittel unterschiedlicher Viskosität (Hylo-Vision 0,1%, 0,2%, 0,3%, OmniVision GmbH, Puchheim, Deutschland) appliziert wurden. Bei 20 gesunden Probanden wurde vor und nach der Applikation der Tränenersatzmittel eine Messung der nicht invasiven Tränenfilmaufreißzeit mittels Keratograph 5M (Oculus GmbH, Wetzlar, Deutschland) sowie mit der optischen Kohärenztomografie mittels 3D OCT-2000 (Topcon, Hamburg, Deutschland) durchgeführt.Das Alter der Probanden lag im Median bei 28,5 Jahren. 11 Frauen (55%) und 9 Männer (45%) wurden untersucht. Die nicht invasive Tränenfilmaufreißzeit hat sich nach Applikation der 0,3%-Hyaluronsäure signifikant (p = 0,027) verbessert. In der Studie wurde bei allen verwendeten OCT-Parametern kein signifikanter Unterschied vor und nach Applikation der unterschiedlich viskosen hyaluronsäurehaltigen Tränenersatzmittel festgestellt.In der Studie konnte kein Einfluss unterschiedlich viskoser hyaluronsäurehaltiger Tränenersatzmittel auf die Messergebnisse der optischen Kohärenztomografie festgestellt werden. Demzufolge können dem Patienten zur Verbesserung der kornealen Oberfläche vor der Untersuchung mit der optischen Kohärenztomografie 0,1%-, 0,2%- und 0,3%-Hyaluronsäure appliziert werden, ohne die Messergebnisse der optischen Kohärenztomografie negativ zu beeinflussen.

The quantitative measurement of the tear film lipid layer thickness is a relatively new and promising method. However, so far it has not been investigated whether there is a diurnal or a day to day variability and whether certain factors are confounding the measurement of the lipid layer thickness.In three different experimental settings, 10 subjects without known sicca syndrome were examined at three different time points on one day, on three different days and before and after therapeutic expression of the Meibomian glands. As a comparison, the parameters tear film break-up time, tear meniscus height, diagnostic expression of the Meibomian glands and subjective symptoms, determined using the OSDI (ocular surface disease index) questionnaire, were measured.The results of the study showed a smaller variation of the lipid layer thickness measurements during the day and from day to day compared to the tear film break-up time. The expression of the Meibomian glands significantly increased the lipid layer thickness. There was a correlation between the baseline values of tear film break-up time and the lipid layer thickness.Our data showed that the lipid layer thickness as measured with the Lipiview® interferometer appears to be a relatively constant parameter over time. In addition, the expression of the Meibomian glands could be identified as a potential confounding factor. In this study we included only healthy subjects without known sicca syndrome. For the future our findings need to be validated in dry eye patients.

Evaporative dry eye is the most common form of tear film dysfunction. The present trial aims to evaluate the efficacy of two established treatment options with different modes of action by comparison.216 patients suffering from evaporative dry eye were included in this prospective, randomised two-centre trial. Divided into two treatment groups, patients either received treatment with hyaluronate artificial tears (Vismed light) or a phospholipid-liposome eye spray (Tears Again), each for three months. Tests (lid-parallel conjunctival folds [LIPCOF], non-invasive break-up time [NIBUT], Schirmer's test, inspection of lids and subjective assessment) were performed before as well as 4 and 12 weeks after initiation of this study.In the patients of the eye spray group there was a significantly greater reduction of the LIPCOF grade (p0.02) and the grade of inflammation of the lid margin (p0.002). With respect to the tear film break-up time (NIBUT) there was a significant difference between the results of both groups (p0.003). The improvement of the break-up time in patients of the eye spray group turned out to be more than twice as high as that in the artificial tears group.Both therapies improved evaporative dry eye, but patients on phospholipid-liposomal eye spray demonstrated greater clinical benefit from their therapy, particularly regarding the degree of inflammation of the lid margins as well as the grade of LIPCOF. When compared to hyaluronate artificial tears, NIBUT more than doubled in the phospholipid-liposome eye spray group. Clinical severity of dry eye is more pronounced when evaporative dry eye and aqueous tear deficiency coincide. A combination of the phospholipid-liposome eye spray and artificial tears appears to represent a considerable advancement in tear replacement therapy for severe cases of dry eye.

Dry eye symptoms can often be observed following vitreo-retinal operations, however, little is known about the frequency and severity of these postoperative problems.Examination of 140 patients following vitreo-retinal surgery ( n=31), brachytherapy ( n=76), proton beam radiation ( n=33) and controls ( n=54) using a questionnaire together with a clinical examination of the anterior segment, tear break-up time and a Schirmer test.Of the treated patients 63% complained of dry eye symptoms versus 40% of the controls ( p=0.004). The tear break-up time was decreased in treated patients ( p0.001, medians: 15 vs. 20 s). No significant difference was seen on the Schirmer test ( p=0.825; medians: 12 vs. 12 mm).Dry eye symptoms are a common postoperative complication following vitreo-retinal surgery and ocular tumour therapy.

In absolute dry eyes the use of pharmaceutical lubricants can be insufficient to prevent progressive conjunctival and corneal epitheliopathy and the severe symptoms associated. In this situation a microvascular autologous submandibular gland transplant can be used to continuously provide a natural tear substitute. We studied the effect of this salivary tear film on the ocular surface in a prospective controlled clinical study.We examined 20 eyes with a viable submandibular gland transplant and 20 severely dry eyes without or with a nonviable transplant as a control for the first postoperative year. Visual acuity, baseline-tear secretion, fluorescein break-up time and slit-lamp microscopical grading of ocular surface features, Rose Bengal staining and conjunctival impression cytology were evaluated.Postoperatively baseline-tear secretion and break-up time were significantly better in the group with a viable submandibular gland transplant than in the controls. The biomicroscopical staging of eyes with a salivary tear film was stable or showed a trend to improvement, while controls showed a trend to deteriorate. A successful submandibular gland transplant reduced the conjunctival and corneal neovascular hyperaemia. However, in 6 eyes with an excessive salivary epiphora, a microcystic epithelial oedema was observed. The epiphora and the associated oedema could be successfully controlled by means of a surgical reduction of the transplant.Following successful autologous submandibular gland transplantation lubrication and comfort are significantly improved and the ocular surface is stabilised during the first postoperative year. Severe preoperative morphological alterations and the salivary character of the new tear film prevent a more obvious improvement of the ocular surface.

Isotretinoin (13-cis-retinoic acid) is commonly used for the treatment of acne vulgaris. In the skin this substance causes an atrophy of sebaceous gland acini and a decrease in sebum production. Systemic treatment also alters meibomian gland function and structure. These alterations seem to be responsible for ocular complications (dryness of the eye, blepharitis, conjunctivitis) during therapy with isotretinoin. We inspected 30 patients before, during and after therapy with isotretinoin with regard to ocular side effects. Examination included careful slit-lamp inspection, measurement of break-up time (BUT) and the Schirmer test. Conjunctival smears were taken from every patient. The most frequently observed side-effects were decreased tear break up time and alterations of the lid margin. In addition, an enormous increase of Staphylococcus aureus in conjunctival flora was noticed. However, all ocular complications of systemic treatment with isotretinoin were reversible after cessation of therapy.

The hyperosmolarity of the tear film is an important clinical sign of dry eye disease. It is the most important diagnostic parameter. In addition to the TearLab osmometer (TearLab Corp, San Diego, CA), which has been available for several years, the I-Pen osmometer (I-MED Pharma Inc, Dollard-des-Ormeaux, Quebec, Canada) has been recently marketed. The intention of our study was to compare tear film osmolarities in normal individuals as measured by TearLab and I-Pen.51 healthy subjects (mean age 40.6 years, range 17 - 63 years, 66.7% females) without dry eye disease (ocular surface disease index 13, tear film break-up time 7 s, normal Schirmer test 10 mm/5 min) were included in this study. Tear film osmolarity was measured in the tear meniscus (TearLab) and the palpebral conjunctiva (I-Pen) with a 30 min interval. The osmolarity testing techniques were alternated. Statistical analysis was performed using Wilcoxon tests and Spearman correlations.Mean TearLab osmolarities were 295.1 mosmol/l (right eye), 294.0 mosmol/l (left eye), and 294.6 mosmol/l (mean of both eyes) with a range of 268 to 394 mosmol/l. I-Pen measured mean osmolarites of 301.6 mosmol/l (right eye), 302.5 mosmol/l (left eye), and 302.1 mosmol/l (mean of both eyes) with a range of 276 to 394 mosmol/l. There was a significant difference in tear film osmolarities for the two techniques for both single eyes (p 0.02) and the mean value of both eyes (p 0.001). TearLab and I-Pen measurements did not correlate significantly in any eye (r = 0.27 and r = 0.08 for right and left eye, respectively). With a cut-off value of 308 mosmol/l (as suggested for TearLab), 98.0% of TearLab values and 68.6% of I-Pen values were in the normal range.I-Pen measured significantly higher tear film osmolarities than TearLab. The location of the measurement site in the palpebral conjunctiva could be responsible for this difference. Our results indicate that cut-off values should be changed when using I-Pen for evaluation of tear film osmolarity. Further examinations and studies with greater cohorts of healthy subjects and patients suffering from dry eye disease are necessary.Die Hyperosmolarität des Tränenfilms gilt als bedeutendes klinisches Zeichen des trockenen Auges und als wichtigster singulärer diagnostischer Parameter. Neben dem seit einigen Jahren verfügbaren Ocusense TearLab-Osmometer (TearLab Corp, San Diego, CA) ist seit Kurzem auch das I-Pen-Osmometer (I-MED Pharma Inc., Dollard-des-Ormeaux, Quebec, Kanada) verfügbar. Das Ziel unserer Studie war die Vergleichbarkeit der mittels TearLab- und I-Pen-Osmometer erhobenen Tränenfilmosmolarität bei gesunden Probanden zu untersuchen.51 gesunde Probanden (mittleres Alter 40,6 Jahre, Altersspanne 17 – 63 Jahre, 66,7% weiblich) ohne Beschwerden und Zeichen eines trockenen Auges (Ocular Surface Disease Index 13, Tränenfilmaufrisszeit 7 s, unauffälliger Schirmer-Test 10 mm/5 min) wurden eingeschlossen. Die Tränenfilmosmolarität wurde im Tränenfilmmeniskus (TearLab) und an der subtarsalen Bindehaut (I-Pen) mit einem Zeitintervall von 30 min erhoben. Die Reihenfolge der beiden Osmolaritätsuntersuchungen erfolgte im alternierenden Wechsel. Die statistische Analyse erfolgte mittels Wilcoxon- und Spearman-Tests.Die mittlere TearLab-Osmolarität war 295,1 mosmol/l (rechtes Auge), 294,0 mosmol/l (linkes Auge) sowie 294,6 mosmol/l (bilateral) mit einer Variationsbreite von 268 – 394 mosmol/l. Mittels I-Pen-Osmometer erhobene mittlere Osmolaritätswerte lagen bei 301,6 mosmol/l (rechtes Auge), 302,5 mosmol/l (linkes Auge) und 302,1 mosmol/l bilateral mit einer Variationsbreite von 276 – 394 mosmol/l. Es zeigte sich ein signifikanter Unterschied in den erhobenen Tränenfilmosmolaritäten mit den beiden Techniken für beide Augen einzeln (p 0,02) und beim Mittelwert beider Augen (p 0,001). Die Messungen mit beiden Geräten korrelierten nicht signifikant (r = 0,27 rechts und r = 0,08 links). Bei einem – wie von TearLab vorgeschlagenen – Grenzwert von 308 mosmol/l lagen 98,0% der TearLab-Werte, aber nur 68,6% der I-Pen-Werte im Normbereich.Die mittels I-Pen gemessenen Osmolaritätswerte zeigten sich signifikant höher im Vergleich zu den mit TearLab erhobenen Messwerten. Für diesen Unterschied verantwortlich könnte u. a. die Lokalisation der Messung an der subtarsalen Konjunktiva mit dem I-Pen im Vergleich zur Messung im Tränenfilmmeniskus mit dem TearLab sein. Es könnte daher notwendig sein, den Grenzwert zur Unterscheidung pathologischer Werte von physiologischen Werten bei Messungen der Tränenfilmosmolarität mit dem I-Pen-Osmometer zu ändern. Weiterführende Untersuchungen an einer größeren Kohorte von Normalprobanden sowie bei Patienten mit trockenem Auge sind hierfür notwendig.

In 30 healthy volunteers the tear-film break-up times of both eyes were determined, comparing one eye with a cut-off filter (customarily used in fluorescein angiography (Schott OG 530, thickness 3 mm] with the common method, not using this filter, in the other eye. By using the filter the variance of observed break-up times is decreased, and the time elapsing after the administration of the dye no longer influences the break-up time significantly. The filter described here is therefore recommended for determining the tear-film break-up time.

The presence of preservatives in topical glaucoma treatments may impact ocular surface function and structure. For treatment to be effective, side effects need to be minimized, in order to promote compliance and allow continuation of therapy. Therefore, in daily clinical practice, it needs to be decided on an individual basis whether a preservative-free treatment is required.This study aimed to develop a questionnaire which helps to quickly and easily identify patients who require preservative-free treatment.A questionnaire was prepared to collect relevant clinical findings needed to make a therapeutic decision (preservative-free required? Yes/No). Moreover, a rating scheme was developed to enable efficient final assessment of the collected data. To check their practicability in daily clinical practice, both instruments were tested in 11 ophthalmological centers in Germany.The questionnaire and rating scheme were easy to use, integrated efficiently into everyday routine, and performed in about 1 min. Data of 1150 glaucoma patients were collected and preservative-free eyedrops recommended for 586 (51 %). Parameters most frequently associated with such a recommendation were a reduced tear film break-up time of 10 s (87.5 %) or marked corneal staining (65.5 %).The presented approach helps to decide within 1 min, in daily clinical practice, whether preservative-free glaucoma threatment should be recommended. Individualized therapy decisions can thus be made, allowing goal-oriented use of preservative-free antiglaucomatosa. This might help to promote compliance and lead to reduced progression of glaucoma.

Blepharitis due to Meibom gland dysfunction (MGD) is presumed to be one of the main reasons for dry eye symptoms which occur in up to 50% of contact lens users. Thus, MGD presumably plays an important role in dry eye in contact lens wearers. In the present prospective, randomized and double blind trial the efficacy of two established treatment options for MGD and blepharitis was evaluated in symptomatic contact lens wearers.In this prospective, randomized 2-centre trial 53 symptomatic contact lens wearers suffering from blepharitis were included. Patients were randomly selected for two treatment groups: group A performed lid margin hygiene using the commonly recommended mild baby shampoo (Bübchen Kinder Shampoo-extra augenmild, Bübchen Werk Ewald Hermes Pharmazeutische Fabrik GmbH, Soest, Germany) and group B performed lid margin hygiene using a phospholipid-liposome solution specially designed for lid hygiene (Blepha Cura, Optima, Moosburg/Wang, Germany), each for 4 weeks. Before as well as 4 weeks after initiation of this study the following tests were performed: standardized subjective assessment using the ocular surface disease index, non-invasive break-up time (NIBUT) and objective evaluation of lid-parallel conjunctival folds (LIPCOF) and further lid margin criteria by double blinded evaluation of slit lamp photographs.Of the 53 symptomatic contact lens wearers suffering from blepharitis 21 (39,6%) were randomly selected for treatment group A and 32 (60.4%) for group B. In both treatment groups there was objective and subjective improvement of symptoms of dry eye in contact lens wearers. Interestingly, there was a significantly greater improvement, subjective as well as objective, in treatment group B which used the phospholipidliposome solution for lid margin hygiene compared to group A using baby shampoo.Although both therapies improved symptoms of dry eye due to blepharitis in symptomatic contact lens wearers, patients using phospholipid-liposomal solution for lid margin hygiene demonstrated a significantly greater clinical benefit from the therapy. Thus, clinical practice recommending just baby shampoo for lid margin hygiene should be re-considered, as phospholipid-liposomal solution for lid margin hygiene appears to yield greater and faster clinical benefits for symptomatic contact lens wearers suffering from dry eye symptoms.

The current understanding of the pathogenesis of dry eye disease has proceeded to recognition of inflammation as the key pathogenetic mechanism. The purpose of this study was to evaluate the effect of cyclosporine 0.05% eye drops on subjective symptoms and objective signs of patients with keratoconjunctivitis sicca.In this clinical trial 62 patients with severe keratoconjunctivitis sicca (DEWS grade 3) were included. Over a time period of 3 months all patients received treatment with preservative-free hyaluronic acid artificial tears at one drop 5 times per day and in addition 31 patients received one drop of cyclosporine 0.05% twice daily. Screening parameters were LIPCOF, tear break-up time (BUT), fluorescein and rose bengal staining, the intraocular pressure (IOP) and the OSDI score.In the cyclosporine A group BUT, Jones test and OSDI score improved significantly after 3 months in contrast to the controls. Moreover the values of BUT and Jones test in the cyclosporine A group were significantly higher after 3 months compared to the healthy controls. Fluorescein and rose bengal staining improved only in the cyclosporine A group after 3 months.Anti-inflammatory therapy with cyclosporine A 0.05% eye drops as off label use significantly improves subjective symptoms and objective signs in patients with severe dry eye disease providing a good safety profile. These findings suggest a widespread use of cyclosporine A 0.05% eye drops in patients with moderate to severe keratoconjunctivitis sicca.

The aim of this study was to evaluate ocular changes in patients with xeroderma pigmentosum (XP) and Cockayne syndrome (CS). Both diseases belong to the progeroid syndromes caused by single gene mutations with premature aging. Both syndromes are very rare autosomal recessive diseases caused by a gene defect leading to deficient DNA repair.12 patients (4 female, 8 male) with XP between 3 and 67 years old and a 39-year-old female patient with CS were examined. The examination included visual acuity testing, slit lamp biomicroscopy, funduscopy and performance of a Schirmer test.Changes of the lids in the XP group included blepharitis in 7 patients, distichiasis in 2, and madarosis in 3 patients. 8 patients had multiple lentigines solares of the lids. One patient showed scars of the lower lids after excision of a squamous cell carcinoma and a basal cell carcinoma. Conjunctival lesions comprised a tumour of unknown origin of the conjunctiva in 1 patient, teleangiectasia of the conjunctiva in 5 patients, pterygia in 4, and pinguecula in 1 patient. Two patients had an intraepithelial melanosis of the conjunctiva, and one showed conjunctival nevi. Two patients had corneal scars and corneal vascularisation, another a significant conjunctivalisation of the cornea. A Schirmer test was feasible only in 3 patients. Tear production was markedly reduced in all these patients. Break-up time was shortened significantly in 6 patients examined. The patient with the CS showed atrophy of the pupillary rim and a subcapsular cataract. Funduscopically there were pigment epithelial changes.Patients with XP often exhibit ocular changes. Beside the light-dependent degenerative and inflammatory manifestations at the lids, the conjunctiva and the cornea patients with XP also develop malignancies early in life. The majority of patients suffer from dry eye symptoms.

The local application of drugs is an efficient method for treating diseases of the external eye. However, some active substances can also cause a chronic toxic reaction at the ocular surface. No results from clinical experiments on the local tolerance of kanamycin which would meet the requirements of evidence-based medicine are as yet available.Thus, the cytomorphological processes of the treatment with kanamycin were examined in a prospective randomised placebo-controlled double blind cross-over study. The effect of the topical application (5 times a day for 7 days) of Kanamycin POS® eye ointment on the conjunctival epithelial barrier was studied in comparison with an eye ointment base (placebo) in 25 healthy subjects. To detect cytopathological microchanges of the epithelium, we carried out a standardised impression cytology (primary compatibility parameter). Biomicroscopy, Schirmer II test and non-invasive measurement of the break-up-time (tearscope) were also examined. The subjective compatibility parameters (itching, tearing, foreign body sensation, burning sensation, mucus) were measured on a 0 - 10 visual analogue scale.The cytological findings of 23 subjects were included in the final evaluation of the study. The impression cytology did not reveal a different effect of kanamycin ophthalmic ointment on the conjunctival ocular surface in comparison with the placebo. Only in one subject was a marked shift found in the nuclear-cytoplasmic ratio after application of verum. No signs of increased apoptosis ("snake-like chromatin") were found at the conjunctival epithelial barrier. The mean goblet cell count was 109 goblet cells per mm (2). No significant reduction of the goblet cell density was found in any treatment group. Among the subjective compatibility parameters, only the mean for itching constantly remained above the placebo group after application of kanamycin. Statistically significant differences were not found by the Wilcoxon test.In contrast to the clinical experience with the systematic application of kanamycin, the standardised evaluation of this study confirmed the very good topical tolerability of the tested kanamycin eye ointment. In view of the continuing clinically relevant aspect of the availability of a wide spectrum of antibiotics to avoid the development of resistance while at the same time keeping within what is reasonable economically, Kanamycin POS® for topical application supplements the options of ophthalmological antibacterial chemotherapy.

A deficiency in the tear film lipid layer is aetiological in about 80 % of the patients suffering from dry eye, which results in excessive evaporation (so-called hyperevaporative dry eye). The treatment with conventional artificial tears did not prove to be successful here. In this study the treatment with two tear substitutes containing lipids were set in contrast with each other.The randomised, controlled, multicentre cross-over study included 74 patients suffering from dry eye caused by a deficiency of the tear film lipid layer, which were organised into two groups. Group A (n = 38) was treated for the first 6 weeks with a liposomal eye spray (Tears Again), while the patients of the group of B (n = 36) were treated with an eye gel containing triglycerides (Liposic) in the same period. After 6 weeks the crossover was performed. The patients were treated in the following 6 weeks with the product which was not used before. Control examinations by masked examiners took place at the beginning of the study as well as after 6 and 12 weeks, considering the following parameters: eyelid edge-parallel conjunctival folds (LIPCOF), BREAK UP time (BUT), Schimer-I test, measurement of the tear meniscus, investigation of the edges of eyelid and visual acuity. In addition. the subjective feelings of the patients were also determined by means of questionnaires.At the beginning of the study the two groups did not differ significantly with respect to the initial values. After the first treatment period the improvement of the examined parameters LIPCOF, BUT, Schirmer, visual acuity and inflammation of the lid margin in group A (eye spray) proved to be significantly superior in comparison to group B (eye gel). The results of the second treatment period after the crossover were similar and showed an analogous supremacy of the liposomal eye spray. The interviews with the patients revealed that the subjective evaluation concerning efficacy and compatibility of the eye spray turned out to be explicitly more favourable than that concerning the eye gel. 74.6 % of the patients favoured the application as an eye spray onto the closed eyelids over the eye gel into the conjunctival sac. 62.5 % of the patients rated the liposomal eye spray to be better all in all, 12.5 % rated that both preparations are equal and 25 % favoured the eye gel.The treatment with phospholipids liposomes shows statistically significant clinical advantages and proves to be favourably and explicitly superior compared to the conventional standard treatment all in all.

The aim of this observation study was to determine whether regression of lid-parallel conjunctival folds (LIPCOF) can be induced by repeated and intensive treatment with a gel-forming tear substitute.In cooperation with the referring ophthalmologists, patients suffering from advanced dry eye condition were recruited. LIPCOF grades from 1 to 3 were included. Tear film break-up time (BUT) had to be less than 10 sec and the Schirmer-I test less than 10 mm. All patients recruited had been using watery tear substitutes. Examinations including visual acuity, slit lamp, fluorescein test, Schirmer-I test, BUT, LIPCOF were performed at baseline and after 2 weeks and 2 months. All examinations were done by the same physician at the Dietrich-Bonhoeffer Eye Hospital of Neubrandenburg. Exclusion criteria were severe eye diseases such as glaucoma, cataract, retinal detachment, history of intraocular or conjunctival surgery and disorders of the eye lids. Pretreatment with gels was not allowed. In the study, patients were treated with Liposic Eye Gel at least three times a day for a period of two months.LIPCOFs regressed in 10 eyes of 5 patients (1 x male, 4 x female) from a mean grade of 2.58 at baseline to 2.29 after 2 months under Liposic treatment. This improvement is statistically significant (n = 10, p = 0.04). Schirmer-I test results had improved in the same time period from a mean of 6.4 mm at baseline to a mean of 8.1 mm after 2 months (n. s., n = 10, p = 0.73). BUT improved from a mean of 12.5 sec at baseline to a mean of 17.5 sec at the 2-month follow-up (n. s., n = 10, p = 0,085). In one patient the cornea was fluorescein-positive at baseline and stayed so throughout the follow-up. Liposic Gel was used by the patients between 3 to 8 times per day. Tolerance was excellent.The study results show that the morphological signs of the dry-eye condition like LIPCOFs can be reversed by intensive treatment with Liposic Gel. The improvements in BUT and Schirmer-I test results confirm the adherence of the patients to the treatment schedule.This pilot study provides the statistical data necessary for designing a major treatment study to prove not only the reversibility of LIPCOF, but also the dependence of the possible improvement on the grade of LIPCOF stage on the age of the patient and on other criteria.

This study was designed to examine if patients undergoing the same operative procedure (blepharochalasis operation) have different subjective recognition of dry eye problems depending n whether they had he operation for cosmetic or medical reasons.The study included 32 patients (25 women, 7 men, mean age 57.8 +/- 12.1 years), who underwent blepharochalasis operation between 1/2005 and 5/2005. In 17 patients (group 1) the operation was done for cosmetic reasons, in 15 patients we found a medical indication (group 2). We evaluated the subjective discomfort from the lid problems as well as the satisfaction with the operation in general and pre- or postoperative recognition of dry eye problems (all done by scales). Additionally we measured tear secretion by Schirmer's test and break-up time before and after operation.The subjective recognition of a dry eye was stronger in group 1 than in group 2 before and after operation (p0.005), but objective data were nearly identically (BUT, Schirmer's test).When operated due to cosmetic reasons the stronger recognition of sicca problems (while objectively lacking) is may be caused by a stronger fixation on the lid disease itself. It seems necessary to document objective data for that reason.

Most of the eye drops currently used replace only the aqueous phase of the tear film. But, due to the fact that, with approximately 80 % of the patients with a dry eye, a disturbance of the lipid phase is present, an approach for new treatment methods needed to be found. We examined a new therapy concept with an eye spray containing liposomes for the therapy of the "dry eye" in a long-term study.An examination of the effectiveness of a liposome eye spray (TEARS AGAIN, Optima Pharmaceutical GmbH, Germany) in patients with "dry eye" compared with a spray containing a balanced salt solution was carried out.Between August 2003 and May 2004 a double-blind study with 382 patients was accomplished. The treatment group (V; n = 191) was compared with the control group (K; n = 191) for a period of 6 months regarding the following examination criteria: eyelid edge parallel conjunctival folds (LIPCOF), BREAK UP time (BUT), Schirmer I test, best corrected visual acuity, as well as slit lamp findings of the cornea and conjunctiva. Follow-up was after 4 weeks and 6 months. The statistical analysis was performed with the statistical program SPSS v.11.5.The examined parameters such as LIPCOF, BUT and Schirmer were significantly better in the treatment group than in the control group. We found likewise significant improvements of the inflammations of the edge of eyelid with a remarkable decrease of around 89.5 %. Questioning of the patients resulted in, among other things, the belief that the liposome eye spray led altogether to a clear subjective improvement of the symptoms in 72 % of the cases, although an initial burning sensation was mentioned after the application. All patients were of the opinion that application with a spray is more favourably and more pleasant than teardrops.The liposome tear substitute shows statistically significant advantages against a balanced salt solution. This new liposome eye spray represents a new, revolutionary and effective procedure in the therapy of the "dry eye". Considering the disturbance of the lipid phase in 80 % of the patients, TEARS AGAIN ought to be a first choice treatment.

An autologous submandibular gland can be transplanted to the temporal fossa and following microvascular anastomosis to the temporal artery and vein and implantation of the secretory duct into the superotemporal conjunctival fornix to provide continuous substitute lubrication. Here we report our experiences with this procedure.In a prospective, controlled clinical cohort study, we investigated the development of the Schirmer- test, fluorescein-break up time (F-BUT), degree of discomfort, use of pharmaceutical tear substitutes, visual acuity, Rose Bengal staining and conjunctival hyperemia in 14 eyes with a successful submandibular gland transplant and 11 dry eyes without salivary lubrication.Over a mean postoperative period of 3.3 years the transplantation group showed significant improvements of the Schirmer-Test, FBUT, use of pharmaceutical tear substitutes, discomfort and Rose Bengal staining up to the last follow-up when compared to the preoperative and control groups.Transplantation of an autologous submandibular gland can improve the lubrication and discomfort of absolute tear deficiency on a long term basis, but the salivary tear film only partially stabilises the ocular surface. The procedure is however able to provide symptomatic relief in extreme cases of absolute dry eyes.

To evaluate the incidence and clinical course of corneal complications in patients with severe dry eye syndrome after hematopoietic stem cell transplantation (HSCT).50 consecutive patients (aged 9-65 years; average=42+/-11 years) with Sjögren-like syndrome after hematopoietic stem cell transplantation were examined. In order to assess the severity of the dry eye syndrome, the frequency of blinking and break-up time were determined and Schirmer-I, fluorescein,and rose bengal tests were carried out. Biopsy and histological examination were performed in cases with suspected conjunctival graft-versus-host reaction.Patients with Sjögren-like dry eye syndrome were referred within an average of 13 months after HSCT (SD+/-20 months).The follow-up was up to 83 months (mean: 10.2 months,SD+/-14.97). Of the 50 patients 15 developed severe corneal complications with significant loss of vision which resulted in enucleation of the eye in 1 patient. Of these 15 patients 4 had a viral and 2 a bacterial keratitis,7 had trophic corneal thinning and sterile ulcers. Two patients had limbal stem cell insufficiency or pseudomembranous conjunctivitis, both due to conjunctival graft-versus-host reaction. Another patient developed a toxic keratopathy, probably induced by cyclosporin A eye drops. Of 50 patients 35 presented with signs of an inactive or active conjunctival graft-versus-host reaction which could be proven histologically in 26 patients.Patients with Sjögren-like dry eye syndrome after hematopoietic stem cell transplantation are at high risk to develop corneal complications.These complications may result from an aggressive extension of the graft-versus-host reaction towards the conjunctiva and/or the lacrimal gland and seem to occur more often during the period of reduction of systemic immunosuppressive therapy.Furthermore, infectious as well as trophic or toxic corneal complications may be supported by local immunosuppressive therapy. We suggest frequent ophthalmological checks of patients receiving hematopoietic stem cell transplantation who need local immunosuppressive therapy or are in the phase of reduction of systemic immunosuppressive therapy

The eye and its adnexa are frequently involved in sarcoidosis. Keratoconjunctivitis sicca is a typical manifestation that is believed to result from aqueous-layer deficiency in context with lacrimal gland disease. In this study we determined which layer of the tear-film might be involved.Fifty-six patients with clinically and histologically proven sarcoidosis were prospectively analysed for symptoms of dry eye, visual acuity, signs of blepharitis, Schirmer II test, rose bengal test, fluorescein staining, break-up time (BUT), and impression cytology (IPC). Deficiencies of the lipid, water and mucin layers were differentiated. The observations were compared with those from a control group of patients with symptoms of "dry eye" (n = 56).All patients in the control group, but only 20 sarcoidosis patients had dry eye symptoms. The BUT in the control group (7.2 +/- 5.4; mean +/- SEM) was shorter (p0.02) than in sarcoidosis patients (8.9 +/- 4.5; mean +/- SEM). Compared with the sarcoidosis patients, conjunctivitis occurred more frequently in the control group (p0.01). Rose bengal staining was positive in 18 sarcoidosis patients, and in 35 patients of the control group (p0.01). Signs of blepharitis, the results of Schirmer test, fluorescein staining and IPC, and the frequent incidence of deficiencies of aqueous layer, lipid layer and combined deficiencies of two or more layers did not differ significantly between the two groups. Deficiencies of the mucin layer were detected in 43 sarcoidosis patients, and in 51 patients in the control group (p0.05).Tear-film deficiencies are common in sarcoidosis patients, even when clinical symptoms are absent. Observations herein suggest that patients with sarcoidosis may not only suffer from deficiencies of the aqueous layer, but also of the mucin and lipid layers.

Conjunctivitis sicca is a chronic disease of the ocular surface. The substitution of tear deficiency with artificial tears is not satisfying in many patients. In a series of patients successfully treated with acupuncture we observed very different effects on each patient. In this study we evaluate the correlation between the effect of acupuncture and the etiology of the dry eyes treated.102 patients (87 women, 15 men) with dry-eye syndrome have been needed 10 sessions, once per week, for 30 minutes. We recorded causal factors according to the traditional chinese medicine (TCM): external and internal factors. External factors were: toxic, allergic, drug-induced, ocular surface inflammation and infection, contact lens and generally external irritations. Internal factors were disorders of hormones, immune system, psychic, and vitamin-A deficiency. Ophthalmologic observation included the slit-lamp examination, Schirmers test II, break-up time of tear film (BUT) and a drop-frequency protocol--before and 1 week after acupuncture treatment.There was a statistically significant difference (p0.001) in Schirmers test, BUT and drop frequency between before and after acupuncture. There was no significant difference between internal and external factors, but the effect on external induced sicca was better. The best effect of acupuncture was found in external factors after inflammation and in patients with imbalance of the autonomic nervous system, the least effects in Sjögren Syndrome. The effect was better in younger then in patients over 50 years.The study demonstrate, according DeLa Fuye that the best effect of acupuncture is seen on functionally disorders.

The classic clinical symptoms of allergic conjunctivitis (type I allergy)--itching and lacrimation--are the effect of histamine. Determination of histamine levels in tears may be useful in evaluating the dynamics of local histamine release in connection with the clinical findings.Between 1.7.1994 and 31.6.1995 we analyzed the histamine levels in tears and investigated the clinical symptoms (score of 0-3) of 32 hyposensitized pollen-sensitive patients (14 males and 18 females, aged 18-45 years, group I) and of 32 controls (group II) without any allergic disease, performed in each case once in season and once out of season. Tear production and composition were measured by Schirmer's test and tear break-up time at the same time. The histamine levels of the tear samples (obtained by microcapillary method) were analyzed by electrochemical determination.In group I there was a highly significant increase of the mean histamine level from 0.89 +/- 2.22 ng/ml (out of season) to 7.71 +/- 7.51 ng/ml (in season) for the right eye and from 0.73 +/- 2.36 ng/ml (out of season) to 9.51 +/- 9.07 ng/ml (in season) for the left eye (P = 0.0000). The histamine level in tears of the controls (group II) was below the detection limit in all samples. The seasonal histamine level were higher with the severity of atopy (Erlangen atopy score). There was no significant influence of age and gender. The reduction of allergic symptoms during hyposensitization was not comparable to the degree of seasonal histamine level. Compared with the clinical findings, the histamine level in tears did not correlate with the symptoms of lacrimation, itching and conjunctival hyperemia.The histamine level in tears alone is not useful as a marker for the clinical severity of this atopyassociated disorder and for the efficacy of the anti-allergic therapy. After standardization of the determination method and the identification of other soluble mediators simultaneously, the histamine level in tears can be used as one part of a profile of mediators to evaluate the clinical symptoms.

In this controlled, randomized, double-masked study the effect of dexpanthenol-containing artificial tears (Siccaprotect) on patients with dry eyes was examined.50 patients applied either dexpanthenol-containing artificial tears (Siccaprotect) or the identical, but free of dexpanthenol, eye drops five times daily into the conjunctival sac. No other ophthalmics were administered. The corneal epithelial permeability was measured by fluorophotometry and Schirmer-Test, Rose Bengal staining, tear film break-up time and the patients' subjective complaints were determined before and after 6 weeks of treatment.The dexpanthenol-containing artificial tears (Siccaprotect) improved disturbances of the corneal epithelial permeability significantly in comparison to the dexpanthenol-free eyes drops. The other parameters didn't show relevant differences.These data suggest that, in dry eyes, treatment with dexpanthenol-containing eye drops leads to a favorable and comparing with dexpanthenol-free eye drops superior improvement in disturbances of corneal epithelium permeability.

Dry eye syndromes are becoming more important for the ophthalmologist. Various circumstances lead to a significant impairment of the three layered precorneal film, whose disturbed equilibrium causes diverse pathological changes in the ocular surface. Apart from symptoms and clinical signs, various clinical tests and laboratory procedures can be used to confirm the diagnosis. We looked at the utility of the lid-parallel conjunctival fold (LIPCOF) with regard to the diagnosis "dry eye". In this publication we describe and classify LIPCOF, stage 0 to stage 3, and investigate its relationship to the severity of dry eye. Dryness is determined by the "sicca score", a scale between 0 and 12 based on a wide-ranging spectrum of tests, including the Schirmer I-test, tear-film break-up time, rose bengal and and fluorescein staining, the lysozyme test and impression cytology. In this prospective study we examined one eye in each of 267 patients, assigning them to one of two groups based on the absence or presence of LIPCOF. These two groups are comparable in gender and age (group-matching). For the diagnosis of dry eye, using LIPCOF, statistical analysis of the data showed a negative predictive value of 75.95% and a positive predictive value of 93.09%. The correlation pattern of LIPCOF with the patient's medical history and slit-lamp. They are a dependable diagnostic sigh of dry eye. Consideration and classification of LIPCOF enlarges and facilitates diagnosis of dry eye syndromes by the ophthalmologist.

Artificial tears often fail in dry eye patients. Our goal was to establish a diagnostic approach that involves alternatives that are more effective for the treatment. We examined 110 patients with dry eyes not stabilized by artificial tears: medical history, visual acuity, slit lamp examination, rose bengal stains and fluorescein stains, Schirmer test, break-up time (BUT), dye tests, impression cytology, and lid transillumination. This allowed disturbances of the three layers of the tear film (lipid, aqueous, mucin) to be differentiated. Cellular damage of the ocular surface was evaluated and scored by slit lamp examination, rose bengal staining, and impression cytology. Only 8% of the patients with "sicca syndrome" had exclusive aqueous deficiencies amenable to artificial tears. In contrast, lipid deficiencies (chronic blepharitis) were determined most frequently (78%). Twenty-six percent had disturbances in two or more layers of the tear film. The diagnostic strategy of differentiating disturbances of the layers of the tear film offers a more specific approach to the treatment of dry eyes.

Diseases of the ocular surface very frequently seen are related to irregularities of wetting. Patients often have complaints and feeling of ill-health, although under symptomatic therapy. Tolerability of the tear substitutes plays a key role in these cases. It is improved with unpreserved medication.59 patients with 'dry eye condition' of various etiology were enrolled in an open multicentre study and treated 8 weeks with a new preservative-free tear substitute. All patients had a history of previous ineffective treatment with artificial tears. The product was formulated with polyvidone and electrolytes in a composition which resembles natural tears. The therapeutic effect was evaluated by ratings of patients' self assessment of their complaints, tear film break up time (BUT), Schirmer I test, visual acuity, biomicroscopic examination and physicians' assessment.Based on the key criteria patients's self assessment and BUT, the new agent (Oculotect fluid sine) improved symptoms and reduced discomfort significantly compared with the previous treatment (paired t test, two-sided, level of significance por = 0.05). The improved condition was confirmed by the other findings taken.In 4/5 of patients, as typically met in ophthalmologists' offices, whose complaints were insufficiently relieved by previously applied tear substitutes, treatment with the new preservative-free product resulted in a distinct improvement of their condition. The lack of preservatives contributed to better tolerability and acceptance of tear substitution.

In this study we examined 85 patients in the range of 25 to 60 years with rheumatoid arthritis (RA) and a control group of 35 persons without any systemic diseases. The 85 patients with RA were split into two groups: first group was made up of 32 patients with keratoconjunctivitis sicca (KCS) and the second of 53 patients without KCS. The aim was to decide whether the simple ocular ferning test has more diagnostic value than the "classical" tests: break-up time (BUT), Schirmer-1-test and concentration of lysozyme in the tear fluid. Therefore, we compared the tests with reference to sensitivity, specificity and prognostic value in the three groups. The results of the ocular ferning test are markedly better than the results of the other tests: sensitivity is 82.2%, specificity 92.5% and prognostic value 86.6%. The corresponding values are: BUT: 51.6%-77.8%-63.1%; Schirmer-1-test: 34.4%-90.8%-73.5%, lysozyme concentration: 73.4%-51.0%-52.7%. The ocular ferning test is an easy, practical, cheap, and reliable completion to the conventional tests; it is also easy on the patients.

Working at video display terminals (VDTs) is particularly demanding in terms of orthopaedic and visual functions. This study was initiated to examine whether, and if so how, VDT work can influence the visual system. It was designed as a 5-year-prospective study based on the matched-pairs technique. The subjects were examined at the beginning and after 5 years of VDT work. The study group consisted of 102 people working at VDTs, and these were paired with 102 other office workers who did not use VDTs. The legally prescribed screening examinations of visual acuity (distance and near vision, phorias, stereopsis, and colour vision) were carried out. We also checked the anterior segments by examination with the slit-lamp and the fundus by ophthalmoscopy. Break-up time, Schirmer-I test, perimetry and tonometry were included in our range of examinations. We found a significant difference in asthenopia and daily hours of VDT work between VDT workers working less than 6 h daily and those working more than 6 h daily. In the study group pre-existing exophoria seemed to increase, but no statistical significance was found on testing. Nor was there any significant difference between the study group and the control group in the parameters examined in the course of the screening examination. In our investigation of monocular VDT workers (n = 3) we could not find any visual problems.

57 patients with dry eye syndrome of various etiology were treated with a preservative-free hydrogel in an open clinical trial. All patients enrolled in the 12 weeks study had a history of pretreatment with usual commercial tear substitutes which was either insufficient for relief of complaints or caused hypersensitivity. Detailed analysis of patients self assessment of their condition (by means of a linear scale), tear film break-up time, Schirmer Test, and physician's assessment of therapeutical results revealed that in about 90% of cases existing patient complaints and findings related to dry eye syndrome were significantly improved by symptomatic therapy with this preservative-free gel.

In 30 subjects without ophthalmological disease the corneal contact time of a new artificial polyacrylic-based tear gel (Vidisic, produced by Dr. Mann, Berlin) was compared with a well-known artificial polyvinyl alcohol-based tear solution. The Vidisic concentration remained in the corneal tear film 7 times longer than the substance it was compared with. In a second study including 7 normal subjects and 5 patients with keratoconjunctivitis sicca, the influence of Vidisic on break-up time (BUT) and the Schirmer test was demonstrated. It was found that tear secretion improved for 2-4 hours (Schirmer test) and the stability of the tear film (BUT) improved for about 6 hours with Vidisic. These results suggest that application of Vidisic four times a day is sufficient for efficatious therapy even in cases of severe keratoconjunctivitis sicca.

The effect of Vidisic (a new jelly artificial tear solution) and an ointment basing on Dexpanthenol on the tear production and the tear film stability was studied both on patients in the intensive care units (ICU) and during operations. In 10 relaxed and ventilated patients of the ICU there was no significant change in the tear production after application of either therapy. In 30 patients, undergoing surgery in endotracheal anaesthesia, the break-up-time and the test according to Schirmer were measured pre- and postoperatively. Like in the ICU-patients no difference in tear production could be found. Regarding the stability of the precorneal tear film however Vidisic was more effective than ointment basing on Dexpanthenol. Especially this clear jelly artificial tear solution allowed in contrast to the ointment a permanent and reliable judgement of the pupillary reaction. In addition the patients felt more comfortable with Vidisic.

The activity of acid phosphatase in the testicular parenchyma of cattle was found to be higher than that in the endometrium. The acid phosphatase of either tissue broke up p-nitrophenylphosphate at a rate twice as high as that reached for di-sodium phenylphosphate. Hydrolysis of phenolphthalein diphosphate was slower and that of beta-glycerophosphate very slow. Two optimum pH values and two isozymes were recordable from acid phosphatase in testicular supernatant and three optimum pH values as well as three isozymes from that in endometrial supernatant. Even concentrations pf 0.2 mM of copper and mercury ions were strongly inhibiting the acid phosphatase, whereas lead and cadmium ions proved less effective. The activity of acid phosphatase from testes dropped by 24 per cent and that from the endometrium by 16 per cent over eight weeks of storage at -20 degrees C. The average activity of alkaline phosphatase in the endometrium was much higher than that in testicular parenchyma. Alkaline phosphatase from testes exhibited the shortest break-up time for p-nitrophenylphosphate, whereas disodium-phenylphosphate was broken up at the highest rate by endometrial alkaline phosphatase. Two isozymes of alkaline phosphatase were recordable each from the testes and endometrium.

The tear break-up was determined in 30 patients with healthy eyes aged from 18 to 67 using two different types of filter combinations: (1) Schott Filter OG 530 and Schott Filter BG 12. (2) Schott Filter OG 530 and Zeiss Filter 485. In view of the filter characteristics, we expected a reduction of the variance of the tear break-up time with the second filter combination. This did not occur. There was no difference between the two filter combinations described according to the Wilcoxon Test on the 5 percent level. The reasons are discussed.