Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques
- Conditions
- Aphakia
- Registration Number
- NCT06389643
- Lead Sponsor
- Military Institute od Medicine National Research Institute
- Brief Summary
Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC)
- Detailed Description
Purpose of the study is to compare two methods of scleral fixation of IOL: two-point fixation of AcrySof MA60AC IOL (Alcon) using Yamane technique and four-point fixation of the Akreos AO60 IOL (Bausch \& Lomb) using polypropylene suture. The investigators rated the BCVA, refractive outcomes, intraocular pressure, and also determined intra- and postoperative complications.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- only adult men and women with aphakia without capsular support
- Fuchs' dystrophy
- corneal haze or scarring
- history of corneal transplantation
- astigmatism of more than 2,0D
- clinically active uveitis
- advanced glaucoma
- macular diseases that affect visual acuity (age-related macular degeneration, diabetic maculopathy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method RE 12 months after surgery Postoperative total refractive error
ECC before and 12 months after surgery corneal endothelial cell density
BCVA before and 12 months after surgery The change of best- corrected visual acuity
- Secondary Outcome Measures
Name Time Method Number of complications from day 1 until 12 months after surgery Rate of complications
Trial Locations
- Locations (1)
Military Institute of Medicine - National Research Institute
🇵🇱Warsaw, Poland
Military Institute of Medicine - National Research Institute🇵🇱Warsaw, Poland