Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques

Not Applicable

Completed

• Conditions: Aphakia
• Interventions: Procedure: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique; Procedure: Four-point scleral fixation of Akreos AO60 IOL

• 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.

Study Timeline

• Study Start: 2021-03-19
• Primary Completion: 2022-09-14
• Study Completion: 2023-09-19
• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yamane technique group	Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique	Yamane technique group
Four-point scleral fixation group	Four-point scleral fixation of Akreos AO60 IOL	Four-point scleral fixation group

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