4 results on '"In-the-bag IOL implantation"'
Search Results
2. Safety and efficacy in pediatric secondary intraocular lens implantation, in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized controlled trial
- Author
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Yingshi Zou, Ling Jin, Bo Qu, Hui Chen, Mingbing Zeng, Xia Li, Xinhua Liu, Lixia Luo, Zhenzhen Liu, and Yizhi Liu
- Subjects
Pediatric aphakia ,Secondary intraocular lens implantation ,Glaucomarelated ,Adverse events ,In-the-bag IOL implantation ,Sulcus IOL implantation ,Medicine (General) ,R5-920 - Abstract
Abstract Background Treatment of pediatric cataract remains challenging because of the extremely high incidence of postoperative adverse events (AEs), especially the AEs related to the locations of secondary implanted intraocular lens (IOL). There are two common locations for secondary IOL implantation in pediatric aphakic eyes: ciliary sulcus or in-the-bag implantation. However, there are currently no large, prospective studies comparing complication rates and visual prognosis of in-the-bag versus ciliarysulcus secondary IOL implantation in pediatric patients. Whether or how much secondary in-the-bag IOL implantation benefits the pediatric patients more than sulcus implantation and deserves to be performed routinely by surgeons remains to be elucidated. Here, we describe the protocol of a randomized controlled trial (RCT) designed to evaluate the safety and efficacy of two approaches of IOL implantation in pediatric aphakia. Methods The study is a multicenter, single-blinded RCT with 10 years of follow-up. Overall, a minimum of 286 eyes (approximately 228 participants assuming 75% have two study eyes) will be recruited. This study will be carried out in four eye clinics across China. Consecutive eligible patients are randomized to undergo either secondary in-the-bag IOL implantation or secondary sulcus IOL implantation. Participants with two eyes eligible will receive the same treatment. The primary outcomes are IOL decentration and the incidence of glaucoma-related AEs. The secondary outcomes include the incidence of other AEs, IOL tilt, visual acuity, and ocular refractive power. Analysis of the primary and secondary outcomes is to be based on the intention-to-treat and per-protocol analysis. Statistical analyses will include the χ 2 test or Fisher’s exact test for the primary outcome, mixed model and generalized estimated equation (GEE) model for the secondary outcome, Kaplan–Meier survival curves for the cumulative probability of glaucoma-related AEs over time in each group. Discussion To the best of our knowledge, this study is the first RCT to evaluate the safety and efficacy of secondary IOL implantation in pediatric aphakia. The results will provide high-quality evidence for the clinical guidelines for the treatment of pediatric aphakia. Trial registration ClinicalTrials.gov NCT05136950. Registered on 1 November 2021.
- Published
- 2023
- Full Text
- View/download PDF
3. Safety and efficacy in pediatric secondary intraocular lens implantation, in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized controlled trial.
- Author
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Zou, Yingshi, Jin, Ling, Qu, Bo, Chen, Hui, Zeng, Mingbing, Li, Xia, Liu, Xinhua, Luo, Lixia, Liu, Zhenzhen, and Liu, Yizhi
- Subjects
- *
INTRAOCULAR lenses , *RANDOMIZED controlled trials , *FISHER exact test , *DEEP brain stimulation , *CHILD patients , *VISUAL acuity - Abstract
Background: Treatment of pediatric cataract remains challenging because of the extremely high incidence of postoperative adverse events (AEs), especially the AEs related to the locations of secondary implanted intraocular lens (IOL). There are two common locations for secondary IOL implantation in pediatric aphakic eyes: ciliary sulcus or in-the-bag implantation. However, there are currently no large, prospective studies comparing complication rates and visual prognosis of in-the-bag versus ciliarysulcus secondary IOL implantation in pediatric patients. Whether or how much secondary in-the-bag IOL implantation benefits the pediatric patients more than sulcus implantation and deserves to be performed routinely by surgeons remains to be elucidated. Here, we describe the protocol of a randomized controlled trial (RCT) designed to evaluate the safety and efficacy of two approaches of IOL implantation in pediatric aphakia. Methods: The study is a multicenter, single-blinded RCT with 10 years of follow-up. Overall, a minimum of 286 eyes (approximately 228 participants assuming 75% have two study eyes) will be recruited. This study will be carried out in four eye clinics across China. Consecutive eligible patients are randomized to undergo either secondary in-the-bag IOL implantation or secondary sulcus IOL implantation. Participants with two eyes eligible will receive the same treatment. The primary outcomes are IOL decentration and the incidence of glaucoma-related AEs. The secondary outcomes include the incidence of other AEs, IOL tilt, visual acuity, and ocular refractive power. Analysis of the primary and secondary outcomes is to be based on the intention-to-treat and per-protocol analysis. Statistical analyses will include the χ2 test or Fisher's exact test for the primary outcome, mixed model and generalized estimated equation (GEE) model for the secondary outcome, Kaplan–Meier survival curves for the cumulative probability of glaucoma-related AEs over time in each group. Discussion: To the best of our knowledge, this study is the first RCT to evaluate the safety and efficacy of secondary IOL implantation in pediatric aphakia. The results will provide high-quality evidence for the clinical guidelines for the treatment of pediatric aphakia. Trial registration: ClinicalTrials.gov NCT05136950. Registered on 1 November 2021. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
4. Minimally invasive technique for the correction of luxation of the lens into the vitreous and in-the-bag IOL implantation
- Author
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D.V. Zhmuryk
- Subjects
luxation of the lens into the vitreous ,surgical treatment ,in-the-bag iol implantation ,Internal medicine ,RC31-1245 - Abstract
Background: The availability of a variety of the methods proposed for the removal of luxated lens and implantation of the intraocular lens (IOL) can make us conclude that, currently, there is no unified surgical tactics for this disorder. Purpose: To develop a minimally invasive technique for the correction of luxation of the lens into the vitreous and in-the-bag IOL implantation. Materials and Methods: Twenty five patients were operated on for the lens luxation secondary to ocular contusion and followed up for a mean of 3 years during September 2011 to February 2016 at the Kyiv Eye Microsurgery Center. Preoperatively, the mean best-corrected visual acuity (BCVA) was 0.14 ±0.16 (range, light perception with accurate projection to 0.5), and the mean intraocular pressure (IOP) was 19.74 ± 2.64 mmHg (range, 18 to 27 mmHg). Results: At day 2, month 1, month 3, month 6, and month 12 following surgery, the BCVA was 0.37 ± 0.21, 0.54 ± 0.20, 0.58 ± 0.23, 0.56 ± 0.22 and 0.57 ± 0.19, respectively (Table 1), and surgically induced astigmatism averaged 1.31 ± 0.62 D, 0.95 ± 0.36 D, 0.75 ± 0.31 D, 0.61 ± 0.25 D and 0.56 ± 0.22 D, respectively. Conclusions: The technique presented allows the surgeon to remove the lens through a small self-sealing incision, with a low incidence of intraoperative and postoperative complications; to implant any soft IOL designs; to restore the normal structure of the eye; and to make an IOL stable and well-centered, with surgically induced astigmatism averaged 0.56±0.22 D and preservation of or improvement in visual acuity to 0.5 or better at the 12 months.
- Published
- 2016
- Full Text
- View/download PDF
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