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CompletedNCT06933654IOLsUpdated Apr 18, 2025

Iris Suture Fixation vs Iris Claw for Correction of Aphakia

An interventional study of IOL implantation surgery for aphkic eye in Aphakic Eye, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-18.

Sponsored by Benha University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Apr 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Aphakic Eye

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Keywords

  • Iris suture fixation , iris claw, aphakia
03

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's enrollment of 50 is below the median of 103 across 52 interventional studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Group A (Iris claw IOL)

    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

  • Active comparator
    Group B (Iris fixation IOL)

    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

  • ProcedureIOL implantation surgery for aphkic eye

    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.

06

What researchers measure

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.

    Time frame: at 6 months postoperatively

07

Study locations

1 site
  • Ebsar Eye Center
    Cairo, 4450113, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2024 to primary completion in Nov 2024, 7 months.

Of 37 interventional studies with no phase under Aphakia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2025
First posted
Apr 18, 2025
StartActual
Apr 1, 2024
Primary completionActual
Nov 30, 2024
CompletionActual
Dec 1, 2024
Last update
Apr 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06933654
Lead sponsor
Benha University
Collaborators
Al-Azhar University
Responsible party
Ehab Mohamed Elsayed Mohamed Saad (Lecturer, Benha University) — Principal investigator
First posted
Apr 18, 2025
Start date
Apr 1, 2024
Primary completion
Nov 30, 2024
Completion
Dec 1, 2024
Last update
Apr 18, 2025

Study contacts

Ehab Saad, Lecturer
principal investigator · Benha University, Ebsar Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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