Iris Suture Fixation vs Iris Claw for Correction of Aphakia

NCT06933654 | Completed

• 2 other identifiers: aphakic correctionBenha University
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate and compare the advantages and disadvantages of iris suture fixation versus iris claw of posterior chamber IOLs

Conditions

Aphakic Eye

Keywords

Iris suture fixation , iris claw, aphakia

Outcome Measures

Primary Outcomes (1)

• Best-corrected visual acuity (BCVA)

  BCVA in logMAR , to evaluate and compare visual recovery between the iris-claw and iris suture-fixated IOL groups.

  at 6 months postoperatively

Study Arms (2)

Group A (Iris claw IOL)

ACTIVE COMPARATOR

included 25 eyes in which the iris claw lens was used, the lens used in this study was the Artisan aphakia IOL (Ophtec BV, Groningen, The Netherlands) which is a PMMA IOL with an 8.5 mm length, 1.04-mm maximum height and 5.4-mm optical zone width.

Procedure: IOL implantation surgery for aphkic eye

Group B (Iris fixation IOL)

ACTIVE COMPARATOR

included 25 eyes were subjected to iris fixation of posterior chamber foldable IOLs. eyes in which a single piece PMMA IOL was implanted. The IOL is 6 mm optic, 12.75 mm overall diameter, and has one eyelet for suture fixation in each haptic. A constant was 118.2.

Procedure: IOL implantation surgery for aphkic eye

Interventions

IOL implantation surgery for aphkic eye PROCEDURE

Aphakic eyes underwent secondary intraocular lens (IOL) implantation using one of two techniques. In Group A, an iris-claw IOL (Artisan aphakia IOL, Ophtec BV, The Netherlands) was implanted and fixated to the mid-peripheral iris via enclavation. In Group B, a posterior chamber foldable PMMA IOL was fixated to the iris using transscleral sutures passed through eyelets in the haptics. All procedures were performed under peribulbar anesthesia using standard aseptic technique, and postoperative management included topical antibiotics and corticosteroids.

Group A (Iris claw IOL); Group B (Iris fixation IOL)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical aphakia with no capsular support, with CDVA 4/60 or better on Snellen chart including: Aphakic eyes after complicated cataract surgery, crystalline lens subluxation (Marfan syndrome, pseudoexofoliation syndrome or trauma), 2nd intervention in traumatized eyes, cases with sublaxated or dislocated IOLs.

You may not qualify if:

• Surgical aphakia with decompensated corneas, aphakic patients with posterior segment pathologies like cystoid macular edema, choroidal neovascular membrane, aphakic patients with insufficient iris tissue, and rubeosis iridis, aphakic patients with intractable glaucoma.

Sponsors & Collaborators

• Benha University: lead
• Al-Azhar University: collaborator

Study Sites (1)

Ebsar Eye Center

Cairo, 4450113, Egypt

Location

MeSH Terms

Conditions

Aphakia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Ehab Saad, Lecturer

  Benha University, Ebsar Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: April 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 1, 2024
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

EG (1)