Aphakia, PostcataractNCT06363448
Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia
A study testing Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia in people with Aphakia, Postcataract, run by Sohag University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Aphakia, Postcataract
- What is being tested?
- Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2024to 30 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 40 years
- aphakic patients (post-traumatic or after complicated cataract surgery without capsular support).
Who cannot join
- Corneal decompensation.
- Jeopardized specular microscopy
- retinal or choroidal detachment
- retained Intraocular foreign body
- uveitis, Scleromalacia
- Reubeosis irides
- previous anti-glaucoma surgery.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ophthalmology department, Sohag University
Sohag, 82511
Elshimaa A.Mateen
Sohag
About this study
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.
Read the detailed description
Properly positioned posterior chamber IOL (PCIOL) offers many advantages over an anterior chamber IOL (ACIOL). The potential advantages of PCIOLs over ACIOLs include a reduction in the number of optical aberrations (e.g. magnification, aniseikonia, lens edge glare, flutter), a decreased incidence of secondary glaucoma, and free movement of the pupil to control the amount of light entering the eye.
The risk for corneal decompensation, secondary glaucoma, and cystoid macular edema may be less with PCIOLs than with ACIOLs. In the absence of capsular support, many techniques have been described to secure the haptics to the sulcus region.
All described techniques focus on IOL haptics fixation to the scleral wall at two or more points. These techniques are not free of complications, including IOL tilt, misalignment, myopic shift, IOL suture rupture, and dislocation. In a previous study, Othman et al compared classic ab-externo two-point IOL fixation with a new technique of IOL scleral fixation based on fashioning trans-scleral, a double rectangular suture sulcus reconstruction (DRSSR) to support the IOL optic, thus providing a cushion to the IOL being positioned in the sulcus.
Aim of
- Conditions
- Aphakia, Postcataract
- Being tested
- Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia
- Medical subject headings
- Aphakia, Postcataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in AphakiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Yamani technique | Active comparator | Yamani technique for aphakia Receives: Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia |
| Proline mesh for aphakia | Active comparator | Proline mesh for aphakia Receives: Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA) in LogMAR
Best corrected visual acuity (BCVA) in LogMAR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 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 Aphakia, PostcataractStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elshimaa A.Mateen, Sohag University
- Investigators
- Elshimaa A.Mateen, Doctor, Principal investigator, Assistant professor of ophthalmology, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363448
- Sponsor's protocol ID
- Soh-Med-24-3-04PD
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Awny I, Mossa EAM, El Saman IS, Sinjab AAA, Mounir A. Yamane Technique Versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia. J Ophthalmol. 2026 Feb 17;2026:3731656. doi: 10.1155/joph/3731656. eCollection 2026.
PubMed 41710000
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia
- ClinicalTrials.gov ID
- NCT06363448
- Acronym / sponsor ID
- Soh-Med-24-3-04PD
- Conditions
- Aphakia, Postcataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Apr 2024 (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.
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.
Detailed description
Properly positioned posterior chamber IOL (PCIOL) offers many advantages over an anterior chamber IOL (ACIOL). The potential advantages of PCIOLs over ACIOLs include a reduction in the number of optical aberrations (e.g. magnification, aniseikonia, lens edge glare, flutter), a decreased incidence of secondary glaucoma, and free movement of the pupil to control the amount of light entering the eye.
The risk for corneal decompensation, secondary glaucoma, and cystoid macular edema may be less with PCIOLs than with ACIOLs. In the absence of capsular support, many techniques have been described to secure the haptics to the sulcus region.
All described techniques focus on IOL haptics fixation to the scleral wall at two or more points. These techniques are not free of complications, including IOL tilt, misalignment, myopic shift, IOL suture rupture, and dislocation. In a previous study, Othman et al compared classic ab-externo two-point IOL fixation with a new technique of IOL scleral fixation based on fashioning trans-scleral, a double rectangular suture sulcus reconstruction (DRSSR) to support the IOL optic, thus providing a cushion to the IOL being positioned in the sulcus.
Aim of
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yamani technique | Active comparator | Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in AphakiaYamani technique for aphakia |
| Proline mesh for aphakia | Active comparator | Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in AphakiaProline mesh for aphakia |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 40 years
- aphakic patients (post-traumatic or after complicated cataract surgery without capsular support).
Key exclusion criteria (7 listed)
- Corneal decompensation.
- Jeopardized specular microscopy
- retinal or choroidal detachment
- retained Intraocular foreign body
- uveitis, Scleromalacia
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 |
|---|---|---|
| Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in AphakiaPatients 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. | Procedure or surgery | Proline mesh for aphakia, Yamani technique |
Primary outcome
Best corrected visual acuity (BCVA) in LogMAR
Time frame: 6 months
Best corrected visual acuity (BCVA) in LogMAR
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 2 May 2025.
- Derived from this study: PubMed 41710000Awny I, Mossa EAM, El Saman IS, Sinjab AAA, Mounir A. Yamane Technique Versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia. J Ophthalmol. 2026 Feb 17;2026:3731656. doi: 10.1155/joph/3731656. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Aphakia, Postcataract
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Active, not recruiting
Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach
Aphakia, Postcataract
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.
Elshimaa A.Mateen, Doctor principal investigator
Assistant professor of ophthalmology, Sohag University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia in people with Aphakia, Postcataract, run by Sohag University at 2 sites 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 2 inclusion and 7 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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) in LogMAR (time frame: 6 months). 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 NCT06363448, 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 2 May 2025.