Pterygium of Right EyeNCT06402643
Comparison of Recurrence Between Mini-SLET and Limbal-Conjunctival Autograft Techniques in Primary Pterygium
A study testing Pterygium Excision in people with Pterygium of Right Eye and Pterygium of Left Eye, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
The surgical treatment options for pterygium, an abnormal growth on the eye's frontal surface can be treated with several surgical techniques. The rates of pterygium coming back varies depending on the surgical technique employed and other factors related to the patient and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium of Right Eye, Pterygium of Left Eye, Pterygium of Both Eyes
- What is being tested?
- Pterygium Excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMexico
- Study dates
- 22 Jun 2024to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary nasal pterygium > 2mm
- Patients who can present and continue follow-up for the duration of the study
- Acceptance to participate in the study by signing the informed consent.
Who cannot join
- Patients with rheumatoid arthritis
- Collagenopathy
- Pregnant
- Infection, conjunctival inflammation or ocular trauma
- Glaucoma
- Previous ocular surgery
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto de oftalmología conde de Valenciana
Mexico City, 06800
Enrique Graue Hernandez, +52 5554421700 ext. 3710, egraueh@gmail.com
Nicolas Kahuam Lopez, +52 5554421700 ext. 3710, nicolas.kahuaml@anahuac.mx
About this study
Official title: Comparative Analysis of Recurrence Rate Between Mini-Slet (Simple Limbal Epithelial Transplantation) Versus Limbal-Conjunctival Autograft Techniques in Primary Pterygium Excision
The surgical treatment options for pterygium, an abnormal growth on the eye's frontal surface can be treated with several surgical techniques. The rates of pterygium coming back varies depending on the surgical technique employed and other factors related to the patient and surgery. The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
Read the detailed description
The surgical treatment options for pterygium, an abnormal growth on the eye's surface, encompass various approaches. These include standard surgical excision, which involves removing the pterygium using traditional surgical methods and more recently Simple Limbal Epithelial Transplantation. Recurrence rate of pterygium varies depending on the surgical technique employed and other factors related to the patient and surgery.The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
- Being tested
- Pterygium Excision
- Keywords
- Pterygium,, Mini-SLET, Conjunctival-Limbal autograft
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pterygium ExcisionProcedure or surgery
Pterygium will be surgically removed utilizing conventional resection techniques, entailing a blunt resection of the head, neck, and body of the pterygium. Subsequent to the resection, the surgical site will be polished using a surgical diamond burr if deemed necessary, and hemostasis will be achieved using bipolar cautery.
| Study group | Role | What they receive |
|---|---|---|
| Mini-SLET. | Experimental | In addition to the standard resection technique, the surgical procedure will include the application of AM with surgical adhesive at the surgical site. Following this, limbal cells will be harvested from the limbus in a resection measuring 2×2 mm, divided into six fragments, and positioned along the limbus border on the AM. Receives: Procedure: Pterygium Excision |
| Conjunctival-Limbal Autograft. | Active comparator | Pterygium will be surgically removed utilizing conventional resection techniques, entailing a blunt resection of the head, neck, and body of the pterygium. Subsequent to the resection, the surgical site will be polished using a surgical diamond burr if deemed necessary, and hemostasis will be achieved using bipolar cautery. In the case of CLAu, an autograft will be procured from the superior temporal bulbar conjunctiva. The autograft will be fixed to the surgical site using surgical adhesive. Receives: Procedure: Pterygium Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Any fibrovascular growth that passes onto the cornea across the limbus, will be considered a recurrence.
Measured: 1 month, 3, months, 6 months and 12 months after surgery.
Secondary outcomes (1)
Postoperative symptoms
Any postoperative symptoms, such as: pain, foreign body sensation, irritation, and tearing.
Measured: 1 month, 3, months, 6 months and 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start22 Jun 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Pterygium of Right 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
- Model description
- The allocation sequence will be generated by an investigator and will
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Graue, Instituto de Oftalmología Fundación Conde de Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402643
- Sponsor's protocol ID
- CI-049-2023
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vera-Duarte GR, Ortiz-Morales G, Muller-Morales CA, Navas A, Ramirez-Miranda A, Graue-Hernandez EO, Kahuam-Lopez N. Mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: Study protocol for a randomized controlled trial. Trials. 2025 Oct 31;26(1):457. doi: 10.1186/s13063-025-09075-3.
PubMed 41174752
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Recurrence Rate Between Mini-Slet (Simple Limbal Epithelial Transplantation) Versus Limbal-Conjunctival Autograft Techniques in Primary Pterygium Excision
- ClinicalTrials.gov ID
- NCT06402643
- Acronym / sponsor ID
- CI-049-2023
- Keywords
- Pterygium,, Mini-SLET, Conjunctival-Limbal autograft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 22 Jun 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 May 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 surgical treatment options for pterygium, an abnormal growth on the eye's frontal surface can be treated with several surgical techniques. The rates of pterygium coming back varies depending on the surgical technique employed and other factors related to the patient and surgery. The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
Detailed description
The surgical treatment options for pterygium, an abnormal growth on the eye's surface, encompass various approaches. These include standard surgical excision, which involves removing the pterygium using traditional surgical methods and more recently Simple Limbal Epithelial Transplantation. Recurrence rate of pterygium varies depending on the surgical technique employed and other factors related to the patient and surgery.The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The allocation sequence will be generated by an investigator and will
| Arm | Type | Receives |
|---|---|---|
| Mini-SLET. | Experimental | Procedure: Pterygium ExcisionIn addition to the standard resection technique, the surgical procedure will include the application of AM with surgical adhesive at the surgical site. Following this, limbal cells will be harvested from the limbus in a resection measuring 2×2 mm, divided into six fragments, and positioned along the limbus border on the AM. |
| Conjunctival-Limbal Autograft. | Active comparator | Procedure: Pterygium ExcisionPterygium will be surgically removed utilizing conventional resection techniques, entailing a blunt resection of the head, neck, and body of the pterygium. Subsequent to the resection, the surgical site will be polished using a surgical diamond burr if deemed necessary, and hemostasis will be achieved using bipolar cautery. In the case of CLAu, an autograft will be procured from the superior temporal bulbar conjunctiva. The autograft will be fixed to the surgical site using surgical adhesive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary nasal pterygium > 2mm
- Patients who can present and continue follow-up for the duration of the study
- Acceptance to participate in the study by signing the informed consent.
Key exclusion criteria (6 listed)
- Patients with rheumatoid arthritis
- Collagenopathy
- Pregnant
- Infection, conjunctival inflammation or ocular trauma
- 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 |
|---|---|---|
| Pterygium ExcisionPterygium will be surgically removed utilizing conventional resection techniques, entailing a blunt resection of the head, neck, and body of the pterygium. Subsequent to the resection, the surgical site will be polished using a surgical diamond burr if deemed necessary, and hemostasis will be achieved using bipolar cautery. | Procedure or surgery | Conjunctival-Limbal Autograft., Mini-SLET. |
Primary outcome
Recurrence rate
Time frame: 1 month, 3, months, 6 months and 12 months after surgery.
Any fibrovascular growth that passes onto the cornea across the limbus, will be considered a recurrence.
1 secondary outcome
Postoperative symptoms
Time frame: 1 month, 3, months, 6 months and 12 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 41174752Vera-Duarte GR, Ortiz-Morales G, Muller-Morales CA, Navas A, Ramirez-Miranda A, Graue-Hernandez EO, Kahuam-Lopez N. Mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: Study protocol for a randomized controlled trial. Trials. 2025 Oct 31;26(1):457. doi: 10.1186/s13063-025-09075-3.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pterygium Excision in people with Pterygium of Right Eye and Pterygium of Left Eye, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrique Graue Hernandez (55 5442 1700, egraueh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 1 month, 3, months, 6 months and 12 months after surgery.). 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 NCT06402643, 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 7 May 2024.