Aphakic EyeIOLsNCT06933654
Iris Suture Fixation vs Iris Claw for Correction of Aphakia
A study testing IOL implantation surgery for aphkic eye in people with Aphakic Eye, run by Benha University at 1 site in Egypt.
Trial summary
Evaluate and compare the advantages and disadvantages of iris suture fixation versus iris claw of posterior chamber IOLs Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphakic Eye
- What is being tested?
- IOL implantation surgery for aphkic eye
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iris Suture Fixation vs Iris Claw for Aphakic Correction
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.
- Conditions
- Aphakic Eye
- Being tested
- IOL implantation surgery for aphkic eye
- Keywords
- Iris suture fixation , iris claw, aphakia
- Medical subject headings
- Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL implantation surgery for aphkic eyeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: IOL implantation surgery for aphkic eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity (BCVA)
BCVA in logMAR , to evaluate and compare visual recovery between the iris-claw and iris suture-fixated IOL groups.
Measured: at 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Apr 2024
- Primary completion30 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aphakic EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
- Investigators
- Ehab Saad, Lecturer, Principal investigator, Benha University, Ebsar Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933654
- Sponsor's protocol ID
- aphakic correction
- Other IDs
- Benha University
- Acronym
- IOLs
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saad EME, Mohammed HEM, Tharwat E, Sakr AM, Abdelhafeez SME, Yusef NM, Rashed MAA, Tawfik AMR, Alsadawy MAH, Abdou ARM, Okasha MG, Alabshihy MSI, Hussein ASA, Ghazala AMA, Abd Elkader GBH, Elhaw MAGM, Eldeen MAEMS, Ali MAA, Elsayed SSE, Sayed TGE. Visual outcome, safety, and complications of iris suture fixation versus iris claw fixation for aphakic correction: a prospective randomized study. BMC Ophthalmol. 2026 Apr 14;26(1):177. doi: 10.1186/s12886-026-04785-x.
PubMed 41981554
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iris Suture Fixation vs Iris Claw for Aphakic Correction
- ClinicalTrials.gov ID
- NCT06933654
- Acronym / sponsor ID
- IOLs / aphakic correction
- Conditions
- Aphakic Eye
- Keywords
- Iris suture fixation , iris claw, aphakia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate and compare the advantages and disadvantages of iris suture fixation versus iris claw of posterior chamber IOLs
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Iris claw IOL) | Active comparator | Procedure: IOL implantation surgery for aphkic eyeincluded 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. |
| Group B (Iris fixation IOL) | Active comparator | Procedure: IOL implantation surgery for aphkic eyeincluded 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOL implantation surgery for aphkic eyeAphakic 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. | Procedure or surgery | Group A (Iris claw IOL), Group B (Iris fixation IOL) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Derived from this study: PubMed 41981554Saad EME, Mohammed HEM, Tharwat E, Sakr AM, Abdelhafeez SME, Yusef NM, Rashed MAA, Tawfik AMR, Alsadawy MAH, Abdou ARM, Okasha MG, Alabshihy MSI, Hussein ASA, Ghazala AMA, Abd Elkader GBH, Elhaw MAGM, Eldeen MAEMS, Ali MAA, Elsayed SSE, Sayed TGE. Visual outcome, safety, and complications of iris suture fixation versus iris claw fixation for aphakic correction: a prospective randomized study. BMC Ophthalmol. 2026 Apr 14;26(1):177. doi: 10.1186/s12886-026-04785-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehab Saad, Lecturer principal investigator
Benha University, Ebsar Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL implantation surgery for aphkic eye in people with Aphakic Eye, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (BCVA) (time frame: at 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06933654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.