PterygiumNCT07277426
Comparing Two Surgical Methods to Prevent Pterygium Regrowth
A study testing Conjunctival Rotational Flap and Conjunctival Autograft in people with Pterygium, run by College of Physicians and Surgeons Pakistan.
Trial summary
This study compares two surgical techniques for preventing the regrowth of a pterygium, a non-cancerous growth on the eye. After surgically removing the pterygium, surgeons will cover the area with either a flap of nearby tissue that is rotated into place (Rotational Flap) or with a free graft of tissue taken from… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pterygium
- What is being tested?
- Conjunctival Rotational Flap and Conjunctival Autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2026to 2 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age 18-60
- Either gender
- Primary pterygium
Who cannot join
- • Collagen vascular disease
- Autoimmune disorders
- Pregnancy
- Ocular surface infection
- Previous limbal surgery
- Recurrent or pseudo-pterygium
- Ocular trauma
- Corneal opacity/degeneration'
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Conjunctival Rotational Flap Compared to Conjunctival Autograft After Surgical Removal of Primary Pterygium: A Randomized Controlled Trial
This study compares two surgical techniques for preventing the regrowth of a pterygium, a non-cancerous growth on the eye. After surgically removing the pterygium, surgeons will cover the area with either a flap of nearby tissue that is rotated into place (Rotational Flap) or with a free graft of tissue taken from under the upper eyelid (Autograft). The main goal is to see which method is better at preventing the pterygium from growing back over a 6-month period. A total of 342 patients with a primary pterygium will be randomly assigned to one of the two surgical groups.
Read the detailed description
This is a single-center, prospective, randomized controlled trial to be conducted at the Department of Ophthalmology, Saidu Group of Teaching Hospital, Swat. The study aims to compare the efficacy of the Conjunctival Rotational Flap versus the Conjunctival Autograft in reducing recurrence rates following primary pterygium excision. Adult patients aged 18-60 with primary pterygium will be enrolled. Participants will be randomly allocated into two groups: Group A (Conjunctival Rotational Flap) and Group B (Conjunctival Autograft). The primary outcome measure is the absence of clinical recurrence, defined as fibrovascular tissue crossing ≥ 1 mm onto the cornea, assessed at the 6-month postoperative follow-up visit via slit-lamp examination. Secondary outcomes may include operative time and postoperative complications. Data will be analyzed using SPSS version 23, with a p-value of ≤ 0.05 considered statistically significant.
- Conditions
- Pterygium
- Being tested
- Conjunctival Rotational Flap, Conjunctival Autograft
- Keywords
- Conjunctival Autograft, Conjunctival Rotational Flap, Pterygium Recurrence
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjunctival Rotational FlapProcedure or surgery
A surgical technique where adjacent conjunctival tissue, remaining partially attached, is rotated to cover the exposed sclera after pterygium excision.
Conjunctival AutograftProcedure or surgery
A surgical technique where a free graft of conjunctiva is harvested from the superior bulbar conjunctiva and sutured or glued over the scleral defect after pterygium excision
| Study group | Role | What they receive |
|---|---|---|
| Rotational Flap | Experimental | A hinged conjunctival flap created adjacent to the excision site and rotated to cover the scleral defect while maintaining partial vascular attachment. Receives: Procedure: Conjunctival Rotational Flap; Procedure: Conjunctival Autograft |
| Conjunctival Autograft | Active comparator | A free conjunctival graft harvested from the superior bulbar conjunctiva and transplanted to the scleral bed after pterygium excision. Receives: Procedure: Conjunctival Rotational Flap; Procedure: Conjunctival Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pterygium Recurrence Rate
Absence of clinical recurrence, defined as a quiet ocular surface with no fibrovascular regrowth ≥ 1 mm onto the cornea, as measured by slit-lamp examination.
Measured: 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 posted11 Dec 2025
- Study start2 Feb 2026 (estimated)
- Primary completion2 Jul 2026 (estimated)
- Study completion2 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies 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
- Participants are randomly assigned to one of two parallel groups for the duration of the study
- Masking
- None (open label)
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faiz ur rahman, College of Physicians and Surgeons Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277426
- Sponsor's protocol ID
- SGTH-Oph-Pterygium-001
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Conjunctival Rotational Flap Compared to Conjunctival Autograft After Surgical Removal of Primary Pterygium: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07277426
- Acronym / sponsor ID
- SGTH-Oph-Pterygium-001
- Conditions
- Pterygium
- Keywords
- Conjunctival Autograft, Conjunctival Rotational Flap, Pterygium Recurrence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 2 Jul 2026 (estimated)
- Study completion
- 2 Jul 2026 (estimated)
- First posted
- 11 Dec 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.
This study compares two surgical techniques for preventing the regrowth of a pterygium, a non-cancerous growth on the eye. After surgically removing the pterygium, surgeons will cover the area with either a flap of nearby tissue that is rotated into place (Rotational Flap) or with a free graft of tissue taken from under the upper eyelid (Autograft). The main goal is to see which method is better at preventing the pterygium from growing back over a 6-month period. A total of 342 patients with a primary pterygium will be randomly assigned to one of the two surgical groups.
Detailed description
This is a single-center, prospective, randomized controlled trial to be conducted at the Department of Ophthalmology, Saidu Group of Teaching Hospital, Swat. The study aims to compare the efficacy of the Conjunctival Rotational Flap versus the Conjunctival Autograft in reducing recurrence rates following primary pterygium excision. Adult patients aged 18-60 with primary pterygium will be enrolled. Participants will be randomly allocated into two groups: Group A (Conjunctival Rotational Flap) and Group B (Conjunctival Autograft). The primary outcome measure is the absence of clinical recurrence, defined as fibrovascular tissue crossing ≥ 1 mm onto the cornea, assessed at the 6-month postoperative follow-up visit via slit-lamp examination. Secondary outcomes may include operative time and postoperative complications. Data will be analyzed using SPSS version 23, with a p-value of ≤ 0.05 considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Rotational Flap | Experimental | Procedure: Conjunctival Rotational Flap, Procedure: Conjunctival AutograftA hinged conjunctival flap created adjacent to the excision site and rotated to cover the scleral defect while maintaining partial vascular attachment. |
| Conjunctival Autograft | Active comparator | Procedure: Conjunctival Rotational Flap, Procedure: Conjunctival AutograftA free conjunctival graft harvested from the superior bulbar conjunctiva and transplanted to the scleral bed after pterygium excision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age 18-60
Key exclusion criteria (8 listed)
- • Collagen vascular disease
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 |
|---|---|---|
| Conjunctival Rotational FlapA surgical technique where adjacent conjunctival tissue, remaining partially attached, is rotated to cover the exposed sclera after pterygium excision. | Procedure or surgery | Conjunctival Autograft, Rotational Flap |
| Conjunctival AutograftA surgical technique where a free graft of conjunctiva is harvested from the superior bulbar conjunctiva and sutured or glued over the scleral defect after pterygium excision | Procedure or surgery | Conjunctival Autograft, Rotational Flap |
Primary outcome
Pterygium Recurrence Rate
Time frame: 6 months postoperatively
Absence of clinical recurrence, defined as a quiet ocular surface with no fibrovascular regrowth ≥ 1 mm onto the cornea, as measured by slit-lamp examination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Conjunctival Rotational Flap and Conjunctival Autograft in people with Pterygium, run by College of Physicians and Surgeons Pakistan.
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 8 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: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Iqbal, MBBS (+923049208484, Miqbalskt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pterygium Recurrence Rate (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2025.