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Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia

S

Sohag University

Status

Completed

Conditions

Aphakia, Postcataract

Treatments

Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia

Study type

Interventional

Funder types

Other

Identifiers

NCT06363448
Soh-Med-24-3-04PD

Details and patient eligibility

About

The study aims to describe a new method of sulcus fixation of intraocular lenses (IOLs) using a prolene mesh and to compare its outcomes with Yamani technique.

Full description

Properly positioned posterior chamber IOL (PCIOL) offers many advantages over an anterior chamber IOL (ACIOL). The potential advantages of PCIOLs over ACIOLs include a reduction in the number of optical aberrations (e.g. magnification, aniseikonia, lens edge glare, flutter), a decreased incidence of secondary glaucoma, and free movement of the pupil to control the amount of light entering the eye.

The risk for corneal decompensation, secondary glaucoma, and cystoid macular edema may be less with PCIOLs than with ACIOLs. In the absence of capsular support, many techniques have been described to secure the haptics to the sulcus region.

All described techniques focus on IOL haptics fixation to the scleral wall at two or more points. These techniques are not free of complications, including IOL tilt, misalignment, myopic shift, IOL suture rupture, and dislocation. In a previous study, Othman et al compared classic ab-externo two-point IOL fixation with a new technique of IOL scleral fixation based on fashioning trans-scleral, a double rectangular suture sulcus reconstruction (DRSSR) to support the IOL optic, thus providing a cushion to the IOL being positioned in the sulcus.

Aim of

Enrollment

20 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients aged 40 years
  • aphakic patients (post-traumatic or after complicated cataract surgery without capsular support).

Exclusion criteria

  • Corneal decompensation.
  • Jeopardized specular microscopy
  • retinal or choroidal detachment
  • retained Intraocular foreign body
  • uveitis, Scleromalacia
  • Reubeosis irides
  • previous anti-glaucoma surgery.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Yamani technique
Active Comparator group
Description:
Yamani technique for aphakia
Treatment:
Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia
Proline mesh for aphakia
Active Comparator group
Description:
Proline mesh for aphakia
Treatment:
Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia

Trial contacts and locations

2

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Central trial contact

Elshimaa A.Mateen, Doctor

Data sourced from clinicaltrials.gov

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