Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aphakia
- Sponsor
- Military Institute od Medicine National Research Institute
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- RE
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •only adult men and women with aphakia without capsular support
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
RE
Time Frame: 12 months after surgery
Postoperative total refractive error
ECC
Time Frame: before and 12 months after surgery
corneal endothelial cell density
BCVA
Time Frame: before and 12 months after surgery
The change of best- corrected visual acuity
Secondary Outcomes
- Number of complications(from day 1 until 12 months after surgery)