Breakthrough Innovation in Pediatric Cataract Treatment: Early Pilot Results Using fixOflex
Secondary opacification of the visual axis remains the most common and challenging complication after pediatric cataract surgery, occurring at significantly higher rates than in adults. Our pilot study addresses this root cause through capsule preservation.
Study Design:
In children with bilateral nuclear cataracts, we compared two approaches:
- One eye received conventional IOL implantation
- The fellow eye received fixOflex endocapsular placement before IOL implantation
Six-Month Observations:
Eyes treated with fixOflex demonstrated:
- Maintenance of clear visual axis
- Enhanced refractive stability
- Superior corrected visual acuity
- Complete absence of anterior capsule phimosis
In contrast, conventionally treated eyes showed progressive opacification and capsule phimosis requiring additional surgical interventions.
Clinical Significance:
This approach suggests potential for improved functional outcomes and reduced need for reoperation during critical developmental periods. By preserving the capsular bag's natural geometry, fixOflex addresses the root cause of complications that standard procedures allow through capsular collapse and fibrosis.
Larger cohorts and extended follow-up are essential to validate these preliminary findings.
*For professional use only. Refer to Instructions for Use (IFU) for complete indications, contraindications, and warnings.*

