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1. Reproducibility of evaluation of optic disc change for glaucoma with stereo optic disc photographs

Author

Miglior, S, Zeyen, T, Pfeiffer, N, Cunha-Vaz, J, Linsen, Mc, Pellicci, L, Janssens, A, van der Veken, A, Nerinckx, F, Boeyden, V, Czupper, M, Wendrix, G, Detry-Morel, M, Kestelyn, P, Van den Abeele, K, Jacobs, K, Decock, C, Goethals, M, Pourjavan, S, Maris, K, Deghislage, C, Kersten, I, Vogel, A, Herkel, U, Schwenn, O, Maser-Wahle, M, Funk, J, Schmidt, B, Akbariyeh, N, Burk, R, Thomsen, A, Grehn, F, Marquardt, D, Orzalesi, N, Rossetti, L, Ferrante, M, Mandelli, L, Marini, S, Bertoni, G, Blini, M, De Molfetta, M, Bonomi, L, Morbio, R, Marraffa, M, Maraini, G, Gandolfi, S, Williams, S, Cimino, L, Dondi, P, Lumbroso, B, Manni, G, Cocco, F, Glorialanza, G, Villani, Cm, Pocobelli, A, Cesareo, M, Cupo, G, Neuschuler, R, Pernini, C, Catalani, R, Ribeiro, L, Faria, I, Pereira, Jm, Chingui, S, Duarte, L, Carvalheira, F, Baltar, A, Simao, A, Arede, J, Magalhaes, A, Abrantes, P, Reina, M, Silva, Jp, Romano, G, Silva, S, Torri, V, Poli, D, Nerviani, C, Tinazzi, A, Floriani, I, Adamsons, I, Caprioli, J, Wormald, R, Heijl, A, Airaksinen, J, Michaelis, J, Shedden, A, Gottfried, E, Hutzelmann, J, Rusk, C, Reines, S, Spector, R, Hombrey, J, Snyder, H, Gacos, J, Snapinn, S, Getson, A, Amos, J, Serruys, K, Malbecq, W, John, E, Chapman, J, Beck, J, Tessi, C, Rao, N, Bottari, Fp, D'Achille, R, Wilkins, A, Bauer, C, Derouwaux, C, Van der Straeten, A, Cunha, M, Santana, R, Andrade, Lg, Bule, S, Melo, R, Baumont, H, and Bonaventura, I

Subjects
medicine.medical_specialty, genetic structures, Optic Disk, Optic disk, Glaucoma, Interobserver reproducibility, Cohen's kappa, Double-Blind Method, Ophthalmology, Optic Nerve Diseases, medicine, Photography, Humans, Observer Variation, Reproducibility, business.industry, Outcome measures, Reproducibility of Results, medicine.disease, eye diseases, Confidence interval, medicine.anatomical_structure, sense organs, business, Optic disc
Abstract

PURPOSE To determine the reproducibility of the assessment for glaucomatous change in serial optic disc stereo-slides. DESIGN Masked interobserver variability study. PARTICIPANTS Serial optic disc stereo-slides from 40 patients. METHODS Three independent ophthalmologists evaluated for change a set of two serial 20 degrees optic disc color stereo-slides of 40 patients. This test set was not from European Glaucoma Prevention Study (EGPS) patients. Each observer performed two evaluations at least 30 days apart and was masked from the temporal sequence of the slides and his or her previous evaluation. Each patient was graded as changed or stable by two-out-of-three agreement. A kappa statistic was used to calculate the intra- and interobserver reproducibility as well as the assignment reproducibility (first consensus versus second consensus). The same procedure was followed to test the reproducibility when another experienced ophthalmologist was added to one of the three reading centers. MAIN OUTCOME MEASURES Reproducibility in evaluating glaucomatous optic disc change. RESULTS The intraobserver reproducibility (95% confidence interval [CI]) in the evaluation of change ranged between 0.79 (0.45-1.14) and 1.00 (0.69-1.31). The interobserver reproducibility (95% CI) in the evaluation of change ranged between 0.45 (0.15-0.75) and 0.75 (0.44-1.06). The assignment reproducibility (first consensus versus second consensus in the evaluation of change) between the senior EGPS readers was 0.94 (0.63-1.25). The assignment reproducibility when another experienced ophthalmologist replaced one of the readers was 0.94 (0.63-1.25). CONCLUSIONS The assignment reproducibility of three expert readers looking for glaucomatous change in serial optic disc stereo-slides was excellent. It remained so when one of the three experts was replaced by another experienced reader.

Published
2003

2. The European glaucoma prevention study design and baseline description of the participants

Author

Miglior, S, Zeyen, T, Pfeiffer, N, Cunha-Vaz, J, Linsen, Mc, Pellicci, L, Janssens, A, van der Veken, A, Nerinckx, F, Boeyden, V, Detry-Morel, M, Kestelijn, P, Van den Abeele, K, Jacobs, K, Decock, C, Goethals, M, Pourjavan, S, Maris, K, Kersten, I, Vogel, A, Herkel, U, Schwenn, O, Maser-Wahle, M, Funk, J, Schmidt, B, Akbariyeh, N, Burk, R, Thomsen, A, Grehn, F, Marquardt, D, Orzalesi, N, Rossetti, L, Ferrante, M, Mandelli, L, Marini, S, Bagno, S, Bertoni, G, Blini, M, De Molfetta, M, Bonomi, L, Morbio, R, Marraffa, M, Maraini, G, Gandolfi, S, Williams, S, Cimino, L, Dondi, P, Lumbroso, B, Manni, G, Cocco, F, Glorialanza, G, Villani, Cm, Pocobelli, A, Cesareo, M, Cupo, G, Neuschuler, R, Pernini, C, Catalani, R, Ribeiro, L, Faria, I, Pereira, Jm, Chingui, S, Duarte, L, Carvalheira, F, Baltar, A, Simao, A, Arede, J, Magalhaes, A, Abrantes, P, Reina, M, Silva, Jp, Romano, G, Silva, S, Torri, V, Poli, D, Nerviani, C, Tinazzi, A, Adamsons, I, Caprioli, J, Wormald, R, Hejil, A, Airaksinen, J, Michaelis, J, Floriani, I, Shedden, A, Gottfried, E, Hutzelmann, J, Rusk, C, Reines, S, Spector, R, Hombrey, J, Snyder, H, Gacos, J, Snapinn, S, Getson, A, Amos, J, Serruys, K, Malbecq, W, John, E, Chapman, J, Beck, J, Tessi, C, Rao, N, Bottari, Fp, D'Achille, R, Wilkins, A, Magerl, K, Bauer, C, Derouwaux, C, Cunha, M, Santana, R, Andrade, Lg, Bule, S, Melo, R, Baumont, H, Bonaventura, I, Miglior, S, Zeyen, T, Pfeiffer, N, Cunha Vaz, J, Torri, V, and Adamsons, I

Subjects
Adult, Male, medicine.medical_specialty, Intraocular pressure, Visual acuity, genetic structures, Visual Acuity, Glaucoma, Ocular hypertension, Thiophenes, Sulfonamide, law.invention, Visual Field Test, Randomized controlled trial, Dorzolamide, Double-Blind Method, Thiophene, law, Ophthalmology, medicine, Humans, Dioptre, Antihypertensive Agents, Intraocular Pressure, Aged, Aged, 80 and over, Sulfonamides, business.industry, Middle Aged, medicine.disease, eye diseases, Europe, Antihypertensive Agent, medicine.anatomical_structure, Research Design, Visual Field Tests, Female, Ocular Hypertension, sense organs, medicine.symptom, Safety, Visual Fields, business, Glaucoma, Open-Angle, Human, Optic disc, medicine.drug
Abstract

Objectives The European Glaucoma Prevention Study seeks to evaluate the efficacy of reducing intraocular pressure (IOP), with dorzolamide to prevent or delay patients affected by ocular hypertension from developing primary open-angle glaucoma. Design Randomized, double-blinded, controlled clinical trial. Participants Patients (age > or =30 years) were enrolled from 18 European centers. The patients fulfilled a series of inclusion criteria including the measurements of IOP (22-29 mmHg), two normal and reliable visual fields (VFs) (on the basis of mean defect and corrected pattern standard deviation/corrected loss of variance of standard 30/II Humphrey or Octopus perimetry), and normal optic disc as determined by the Optic Disc Reading Center (vertical and horizontal cup-to-disc ratios; asymmetry between the two eyes Intervention Patients were randomized to the treatment with dorzolamide or a placebo. Main outcome measures End points are VF and/or optic disc changes. A VF change during the follow-up must be confirmed by two further positive tests. Optic disc change is defined by the agreement of two out of three independent observers evaluating optic disc stereo-slides. Results One thousand seventy-seven subjects were randomized between January 1, 1997 and May 31, 1999. The mean age was 57.03 +/- 10.3 years; 54.41% were women and 99.9% were Caucasian. Mean IOP was 23.6 +/- 1.6 mmHg in both eyes. Mean visual acuity was 0.97 +/- 0.11 in both eyes; mean refraction was 0.23 +/- 1.76 diopters in the right eye and 0.18 +/- 1.79 diopters in the left eye. Previous use of medication for ocular hypertension was reported by 38.4% of the patients, systemic hypertension by 28.1%, cardiovascular diseases by 12.9%, and diabetes mellitus by 4.7%. The qualifying VFs were normal and reliable according to protocol criteria. Conclusions The mean IOP of the patients enrolled in the European Glaucoma Prevention Study is consistent with the estimated mean IOP (within the range of 22-29 mmHg) found in a large sample of the European population. The European Glaucoma Prevention Study should be able to better address the clinical question of whether pharmacological reduction of IOP (by means of dorzolamide) in ocular hypertension patients at moderate risk for developing primary open-angle glaucoma effectively lowers the incidence of primary open-angle glaucoma.

Published
2002

5. Intraobserver and interobserver reproducibility in the evaluation of optic disc stereometric parameters by Heidelberg retina tomograph

Author

Luca Rossetti, Nicola Orzalesi, Magda Guareschi, Stefano Miglior, Elena Albè, Miglior, S, Albé, E, Guareschi, M, Rossetti, L, and Orzalesi, N

Subjects
Adult, medicine.medical_specialty, Intraclass correlation, Optic Disk, Optic disk, Laser, Reproducibility of Result, Glaucoma, Interobserver reproducibility, Standard deviation, Ophthalmoscopy, Optic Nerve Disease, Optic Nerve Diseases, medicine, Humans, Tomography, Aged, Observer Variation, Reproducibility, medicine.diagnostic_test, business.industry, Lasers, Reproducibility of Results, Middle Aged, medicine.disease, Surgery, Ophthalmology, medicine.anatomical_structure, Nuclear medicine, business, Glaucoma, Open-Angle, Human, Optic disc
Abstract

Purpose: To assess intraobserver and interobserver reproducibility of the measurement of stereometric parameters of the optic disc by means of the Heidelberg Retina Tomograph I (HRT). Study design: Observational study, with interobserver variability. Participants: Fifty-five volunteers (healthy subjects and patients with glaucoma). Methods: HRT examination of the optic disc was repeated on 3 consecutive days on 1 eye of each of the 55 subjects. During each session, five single images were randomly acquired by two independent observers. One mean topography image (MTI), based on three single images, was then built at each session. For the intraobserver intraimage evaluation, the two observers traced their own contour line on one randomly chosen MTI. This procedure was repeated three times. For the intraobserver interimage and interobserver intra/interimage evaluations, the two observers traced their own contour line on the MTI of the first session, which was then automatically superimposed on the MTIs of the other two sessions. Main Outcome Measures: Reproducibility of the 12 stereometric parameters was calculated for each observer by means of the intraclass correlation coefficient (ICC). The expected range of variability between two independent evaluations was calculated by the scatter-plots of each test-retest difference versus their mean. The standard deviation of the mean test-retest score differences was used to describe the spread of score differences. Results: The ICC ranged between 0.79 and 0.99 for intraobserver intraimage and between 0.56 and 1 for intraobserver interimage evaluation. The ICC ranged between 0.54 and 0.99 for interobserver intraimage and between 0.65 and 0.97 for the interobserver interimage evaluation. ICC was almost perfect to perfect for planimetric measures (0.81 < ICC ≤ 1), substantial to almost perfect for volumetric and cup measures (0.61 < ICC ≤ 0.99), and moderate to almost perfect for retinal nerve fiber layer related measures (0.41 < ICC < 0.99). The expected variability was low (95% confidence interval

Published
2002

6. The IOL-Vip System: a double intraocular lens implant for visual rehabilitation of patients with macular disease.

Author

Orzalesi N, Pierrottet CO, Zenoni S, and Savaresi C

Subjects
Aged, Aged, 80 and over, Cell Count, Endothelium, Corneal pathology, Female, Humans, Male, Middle Aged, Phacoemulsification, Pilot Projects, Postoperative Complications, Treatment Outcome, Visual Acuity, Anterior Chamber surgery, Lens Capsule, Crystalline surgery, Lens Implantation, Intraocular, Lenses, Intraocular, Macular Degeneration rehabilitation, Vision, Low rehabilitation
Abstract

Purpose: To investigate the efficacy of a new surgical and rehabilitative procedure designed to improve vision in patients with central scotoma due to macular diseases., Design: Case series of 40 consecutive surgical and rehabilitative procedures., Participants: Forty eyes of 35 consecutive patients with a stable central scotoma due to macular disease underwent phacoemulsification cataract surgery with the implant of the IOL-Vip System., Methods: The IOL-Vip System consists of a biconcave high minus-power intraocular lens (IOL) in the capsular bag and a biconvex high plus-power IOL in the anterior chamber, reproducing an intraocular Galilean telescope with x1.3 magnification for distance. Selection of the candidate patients was carried out by means of a low-vision diagnostic and rehabilitative program (IOL-Vip software) that evaluates the residual visual function of patients and prognosis for visual improvement based on simulation of the postoperative condition. The software also designs the rehabilitation strategies based on preoperative and postoperative training of the preferred retinal locus., Main Outcome Measures: Best-corrected visual acuity (BCVA), evaluated by means of the Early Treatment Diabetic Retinopathy Study charts and procedure; reading magnification; and reading distance., Results: All patients showed an improvement of visual acuity (VA) due to the surgical and rehabilitative procedure, confirming or exceeding the preoperative expected results. Mean postoperative BCVA was 0.77 (logarithm of the minimum angle of resolution), compared with 1.28 preoperatively. The mean postoperative best reading magnification gain was x6.2, and the mean postoperative reading distance gain was 7.66 cm. No cases of intraoperative or postoperative complications were detected, and the implant was subjectively well tolerated in both monocular and binocular procedures., Conclusion: In this pilot study, the IOL-Vip System was shown to be effective and apparently well tolerated in improving the vision of patients with macular disease. Best-corrected VA, reading magnification, and reading distance improved in all cases of this low-vision patient series.

Published
2007
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7. Intraobserver and interobserver reproducibility in the evaluation of optic disc stereometric parameters by Heidelberg Retina Tomograph.

Author

Miglior S, Albé E, Guareschi M, Rossetti L, and Orzalesi N

Subjects
Adult, Aged, Humans, Lasers, Middle Aged, Observer Variation, Reproducibility of Results, Tomography methods, Glaucoma, Open-Angle diagnosis, Ophthalmoscopy methods, Optic Disk pathology, Optic Nerve Diseases diagnosis
Abstract

Purpose: To assess intraobserver and interobserver reproducibility of the measurement of stereometric parameters of the optic disc by means of the Heidelberg Retina Tomograph I (HRT)., Study Design: Observational study, with interobserver variability., Participants: Fifty-five volunteers (healthy subjects and patients with glaucoma)., Methods: HRT examination of the optic disc was repeated on 3 consecutive days on 1 eye of each of the 55 subjects. During each session, five single images were randomly acquired by two independent observers. One mean topography image (MTI), based on three single images, was then built at each session. For the intraobserver intraimage evaluation, the two observers traced their own contour line on one randomly chosen MTI. This procedure was repeated three times. For the intraobserver interimage and interobserver intra/interimage evaluations, the two observers traced their own contour line on the MTI of the first session, which was then automatically superimposed on the MTIs of the other two sessions., Main Outcome Measures: Reproducibility of the 12 stereometric parameters was calculated for each observer by means of the intraclass correlation coefficient (ICC). The expected range of variability between two independent evaluations was calculated by the scatter-plots of each test-retest difference versus their mean. The standard deviation of the mean test-retest score differences was used to describe the spread of score differences., Results: The ICC ranged between 0.79 and 0.99 for intraobserver intraimage and between 0.56 and 1 for intraobserver interimage evaluation. The ICC ranged between 0.54 and 0.99 for interobserver intraimage and between 0.65 and 0.97 for the interobserver interimage evaluation. ICC was almost perfect to perfect for planimetric measures (0.81 < ICC < or = 1), substantial to almost perfect for volumetric and cup measures (0.61 < ICC < or = 0.99), and moderate to almost perfect for retinal nerve fiber layer related measures (0.41 < ICC < 0.99). The expected variability was low (95% confidence interval, < +/-9%). Interimage evaluation showed a higher variability than intraimage evaluation in both of interobserver (P = 0.012) and intraobserver evaluation (P = 0.028 and P = 0.031 for the two observers)., Conclusions: Measurement of optic disc stereometric parameters by HRT is highly reproducible. However, the use of retinal nerve fiber layer-related parameters should be taken cautiously. The image acquisition-induced variability seems larger than the operator-induced variability.

Published
2002
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8. Laser treatment of feeder vessels in subfoveal choroidal neovascular membranes: a revisitation using dynamic indocyanine green angiography.

Author

Staurenghi G, Orzalesi N, La Capria A, and Aschero M

Subjects
Aged, Aged, 80 and over, Choroidal Neovascularization etiology, Choroidal Neovascularization pathology, Female, Follow-Up Studies, Humans, Macular Degeneration complications, Male, Middle Aged, Pilot Projects, Reoperation, Treatment Outcome, Visual Acuity, Choroid blood supply, Choroidal Neovascularization surgery, Fluorescein Angiography, Fovea Centralis, Indocyanine Green, Laser Therapy
Abstract

Objective: This study aimed to determine whether the indocyanine green angiography (ICGA)-guided laser treatment of feeder vessels (FVs) may be useful in the management of the subfoveal choroidal neovascular membranes (CNVM) in patients with age-related macular degeneration (ARMD)., Design: Noncomparative case series., Participants: The authors considered a series of 15 patients with subfoveal CNVM in whom feeder vessels could be clearly detected by means of dynamic ICGA but not necessarily with fluorescein angiography (FA). On the basis of the indications of the pilot study, the authors also studied a second series of 16 patients with FVs smaller than 85 microm., Intervention: Treatment of FV using argon green laser was performed. The ICGA was performed immediately after treatment, after 2, 7, 30 days, and then every 3 months, to assess FV closure. If an FV appeared to be still patent, it was immediately retreated and the follow-up was started again. The follow-up time ranged from 23 to 34 months for the pilot study and from 4 to 12 months for the second series., Main Outcome Measures: The obliteration of the membrane and change in visual acuity from baseline were measured. The effect on the treatment of the number and width of the FVs, and the size and location of the membrane, also was evaluated., Results: In the pilot study, the CNVM was obliterated after the first treatment in only one patient, five patients needed more than one treatment, and obliteration failed in nine patients (40% success rate). The rate of success was affected by the width and number of the FVs. The success rate in the second series of 16 patients was higher (75%)., Conclusions: The success of the laser treatment of FVs depends on their width, length, and number. Dynamic ICGA, which detects smaller FVs and makes it possible to control the laser effect and initiate immediate retreatment in the case of incomplete FV closure, should be considered mandatory for this type of treatment; a comparable success rate would have been unlikely using the other currently available methods of treating subfoveal CNVMs.

Published
1998
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