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

M

Military Institute od Medicine National Research Institute

Status

Completed

Conditions

Aphakia

Treatments

Procedure: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique
Procedure: Four-point scleral fixation of Akreos AO60 IOL

Study type

Interventional

Funder types

Other

Identifiers

NCT06389643
11/WIM/2021

Details and patient eligibility

About

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)

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Four-point scleral fixation group
Active Comparator group
Description:
Four-point scleral fixation group
Treatment:
Procedure: Four-point scleral fixation of Akreos AO60 IOL
Yamane technique group
Active Comparator group
Description:
Yamane technique group
Treatment:
Procedure: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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