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First Clinical Data on Primary Implantation of a Dedicated Pediatric Modular Intraocular Lens in Infants
Yevgeniy N Batkov1, Maxim V Sinitsyn1, Nadezhda A Pozdeyeva1
1S. Fyodorov Eye Microsurgery Federal State Institution and the Department of Ophthalmology, Postgraduate Medical Institute, Health Ministry of Chuvash Republic, Cheboksary, Russia.
Insights
This study shows a new modular intraocular lens (IOL) is safe for early implantation in pediatric cataract surgery. The implant allows for future adjustments to correct vision changes in children.
Area of Science:
- Ophthalmology
- Pediatric Surgery
- Biomedical Engineering
Background:
- Congenital cataracts affect vision in infants.
- Intraocular lenses (IOLs) are used to restore vision after cataract removal.
- Pediatric IOLs require specific design considerations for growing eyes.
Purpose of the Study:
- To evaluate the early implantation outcomes of a novel pediatric modular intraocular lens (IOL).
- To assess the safety and feasibility of this new IOL in infants with congenital cataracts.
Main Methods:
- Prospective cohort study of 11 pediatric patients undergoing cataract surgery.
- Implantation of a two-piece, hydrophobic acrylic modular IOL with an exchangeable optic.
- Surgical procedure included lens aspiration, IOL placement, posterior capsulectomy, and anterior vitrectomy.
Main Results:
- The surgery was uneventful in all 14 eyes.
- No intraoperative or implant-related postoperative complications were observed.
- A 21% rate of retrolenticular visual axis opacification occurred, requiring surgical intervention.
Conclusions:
- The pediatric modular IOL demonstrated an acceptable safety profile in early implantation.
- The implantation technique is comparable to standard non-adjustable IOLs.
- The modular design offers potential for future refractive correction in pediatric patients.
Purpose:
To report early implantation results of a pediatric modular intraocular lens (IOL).
Methods:
This prospective cohort study included 14 consecutive eyes of 11 patients (4 boys, 7 girls) with visually significant congenital cataract who had surgery in the first year of life at a single clinical site. Intervention involved lens aspiration, IOL placement, primary pars plana posterior capsulectomy and anterior vitrectomy. A two-piece hydrophobic acrylic device composed of an 11-mm haptic and a 5.5-mm exchangeable optic disc was injected into the bag in one piece after prior ex vivo assembly.
Results:
Mean patient age at the time of surgery was 6.2 ± 3.0 months. On average the patients were followed up for 8.2 ± 7.9 months. Mean targeted initial refraction was 4.11 ± 1.68 diopters. The surgery was uneventful in every case. There were no intraoperative or implant-related postoperative complications. Three eyes (21%) developed retrolenticular visual axis opacification necessitating surgical clearing.
Conclusions:
The dedicated pediatric modular implant demonstrated acceptable intraoperative and early postoperative safety profile. Given extraocular assembly of the study IOL, its implantation procedure is technically comparable to that of regular non-adjustable IOLs, whereas its modular design allows for future optical modification to address changing refractive status.
