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

Aphakia, Postcataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363448
• Other study ID #: Soh-Med-24-3-04PD
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: April 2024
• Source: Sohag University
• Contact: Elshimaa A.Mateen, Doctor
• Phone: 021282223427
• Email: elshimaa.moussa[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia
• Aphakia, Postcataract

Intervention

Procedure:
• Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia
Patients were divided into two groups to undergo classic ab externo two-point scleral fixation or flanged haptics as described by Yamani or the 2*2 proline mesh technique.

Locations

Country	Name	City	State
Egypt	Elshimaa A.Mateen	Sohag
Egypt	Ophthalmology department, Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity (BCVA) in LogMAR	Best corrected visual acuity (BCVA) in LogMAR	6 months