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Completed

NCT Number: NCT06933654

Iris Suture Fixation vs Iris Claw for Correction of Aphakia

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

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Key information

Conditions

Aphakic Eye Aphakia Eye Diseases Lens Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ebsar Eye Center

Cairo, 4450113, Egypt

About this study

The eyes were randomly divided into two groups, A and B. Group A included 25 eyes in which an iris claw lens was used; specifically, the Artisan aphakia intraocular lens (Ophtec BV, Groningen, The Netherlands), a PMMA IOL with an 8.5 mm length, 1.04 mm maximum height, and a 5.4 mm optical zone width. Group B also included 25 eyes, in which iris fixation of posterior chamber foldable IOLs was performed using a single-piece PMMA IOL. This IOL had a 6 mm optic, a total diameter of 12.75 mm, and featured one eyelet for suture fixation in each haptic. The A-constant used was 118.2.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Best-corrected visual acuity (BCVA)

    Time frame: at 6 months postoperatively

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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • Al-Azhar University

Registry information

Official study title

Iris Suture Fixation vs Iris Claw for Aphakic Correction

Acronym: IOLs

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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