NCT06363448

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 3, 2024

Last Update Submit

April 29, 2025

Conditions

Aphakia, Postcataract

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity (BCVA) in LogMAR

    Best corrected visual acuity (BCVA) in LogMAR

    6 months

Study Arms (2)

Yamani technique

ACTIVE COMPARATOR

Yamani technique for aphakia

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

Proline mesh for aphakia

ACTIVE COMPARATOR

Proline mesh for aphakia

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

Interventions

Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in AphakiaPROCEDURE

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.

Proline mesh for aphakiaYamani technique

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ophthalmology department, Sohag University

Sohag, 82511, Egypt

Location

Elshimaa A.Mateen

Sohag, Egypt

Location

MeSH Terms

Conditions

Aphakia, Postcataract

Condition Hierarchy (Ancestors)

AphakiaLens DiseasesEye Diseases

Study Officials

  • Elshimaa A.Mateen, Doctor

    Assistant professor of ophthalmology, Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 12, 2024

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)