Primary Pterygium, ASOCT, Conjunctival Autograft SurgeryASOCTNCT07307820
Sutureless Glueless Technique Versus Interrupted Suturing for Conjunctival Autograft Fixation After Primary Pterygium Excision: Anterior Segment Optical Coherence Tomography (ASOCT) Study
A study testing sutured conjunctival autograft fixation and Sutureless Conjunctival Autograft Fixation in people with Primary Pterygium, ASOCT, Conjunctival Autograft Surgery, run by Minia University at 1 site in Egypt.
Trial summary
This study aims to compare the clinical and Anterior segment optical coherence tomography (ASOCT) outcomes between sutured and sutureless conjunctival autograft fixation techniques in the management of primary pterygium. A total of 30 patients with bilateral primary pterygia were included. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Primary Pterygium, ASOCT, Conjunctival Autograft Surgery
- What is being tested?
- sutured conjunctival autograft fixation and Sutureless Conjunctival Autograft Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria Age 18 to 65 years (both sexes). Diagnosis of bilateral primary nasal pterygium requiring surgical excision (both eyes affected).
Horizontal corneal encroachment of the pterygium ≥ 2.0 mm in each eye. Lesions amenable to conjunctival autograft coverage with expected graft size obtainable from superior bulbar conjunctiva.
Willingness and ability to attend scheduled follow-up visits for 1 month postoperatively.
Able to provide written informed consent.
Exclusion Criteria Recurrent pterygium in either eye. Previous ocular surgery on the study eye(s) (including prior pterygium surgery) or conjunctival grafting.
Active ocular surface disease or infection (e.g., conjunctivitis, keratitis) at screening.
Severe dry eye disease (e.g., Schirmer's test ≤ 5 mm or TBUT < 5 s) likely to affect healing.
Significant ocular comorbidities affecting wound healing or outcome interpretation: uncontrolled glaucoma with conjunctival filtering surgery, ocular surface cicatrizing disorders (e.g., ocular pemphigoid), severe blepharitis, or severe meibomian gland dysfunction.
Systemic conditions that impair wound healing or increase surgical risk (e.g., uncontrolled diabetes mellitus with HbA1c > 8.0%, connective tissue disorders, immunosuppression, chronic systemic corticosteroid use).
Current use of anticoagulant therapy that cannot be safely paused per local perioperative protocol (if this precludes safe graft fixation).
Pregnancy or breastfeeding. Known allergy to any material used in the procedure or postoperative medications.
Inability to comply with follow-up schedule or provide informed consent (e.g., cognitive impairment, planning to move away).
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the clinical and Anterior segment optical coherence tomography (ASOCT) outcomes between sutured and sutureless conjunctival autograft fixation techniques in the management of primary pterygium.
A total of 30 patients with bilateral primary pterygia were included. Each patient underwent pterygium excision in both eyes: one eye received graft fixation using interrupted 10-0 nylon sutures, while the fellow eye received sutureless fixation. Allocation of technique between eyes was randomized.
Read more
All surgeries were performed by the same surgeon, and patients were followed up weekly for one month. Parameters assessed included graft thickness, interface reflectivity, gutter size, conjunctival congestion, donor site healing, and postoperative discomfort using a visual analogue scale.
The study evaluates which fixation method provides faster healing, better cosmetic results, and fewer complications such as graft slippage or recession, especially in relation to pterygium size.
- Being tested
- sutured conjunctival autograft fixation, Sutureless Conjunctival Autograft Fixation
- Keywords
- Primary pterygium, ASOCT, conjunctival autograft surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sutured conjunctival autograft fixationProcedure or surgery
After pterygium excision, a conjunctival autograft is secured in place using interrupted 10-0 nylon sutures to ensure graft stability and promote healing
Sutureless Conjunctival Autograft FixationProcedure or surgery
Following pterygium excision, the conjunctival autograft is placed without sutures, relying on natural adhesion and fibrin clot formation to maintain graft position.
| Study group | Role | What they receive |
|---|---|---|
| sutured conjunctival autograft fixation | Experimental | conjunctival autograft secured with interrupted 10/0 nylon after pterygium exision Receives: Procedure: sutured conjunctival autograft fixation |
| sutureless glueless conjunctival autograftfixation | Experimental | Conjunctival autograft placed without sutures, relying on natural adhesion and fibrin clot formation. Receives: Procedure: Sutureless Conjunctival Autograft Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft stability: incidence of slippage or recession (%) - Secondary (Safety/Complication)
Proportion of eyes with clinically significant graft slippage or marginal recession requiring intervention or observed during follow-up.
Measured: Time Frame: Within 1 month postoperatively
Patient-reported discomfort (VAS 0-10) - Secondary
Mean Visual Analogue Scale (0 = no discomfort to 10 = worst possible) recorded at each visit.
Measured: Time Frame: Day 1, Week 1, Week 2, Week 3, Week 4
Cosmetic outcome - surgeon-rated score (0-10)
Surgeon's cosmetic grading based on redness, graft contour and surface smoothness (0 = poor to 10 = excellent).
Measured: Time Frame: 4 weeks (Month 1) postoperatively
Secondary outcomes (9)
Interface reflectivity (qualitative grading: low/moderate/high)
Qualitative grading of graft-host interface reflectivity on AS-OCT to indicate edema/fibrosis; images assessed by masked grader(s).
Measured: Time Frame: Week 1, Week 2, Week 3, Week 4
Change in central graft thickness (µm) -
Absolute and percent change in central graft thickness from Day 1 to Week 4 measured by AS-OCT.
Measured: Baseline (Day 1) to Week 4
Mean central graft thickness measured by AS-OCT (µm)
Description: Mean central conjunctival autograft thickness measured by anterior-segment OCT at 4 weeks after surgery. Measurement performed using device calipers on the central graft area; reported as mean ± SD per group. This endpoint assesses final early structural integration and resolution of postoperative edema.
Measured: Time Frame: 4 weeks (Month 1) postoperatively
Conjunctival congestion score (0-3)
Clinician-graded vascular hyperemia (0 = none; 1 = mild; 2 = moderate; 3 = severe) at each visit.
Measured: Time Frame: Day 1, Week 1, Week 2, Week 3, Week 4
Gutter size at graft-host junction (µm)
Linear measurement of the graft-host interface gap (gutter) by AS-OCT at each follow-up; reported as mean ± SD.
Measured: Time Frame: Week 1, Week 2, Week 3, Week 4
Operative time (minutes) - Secondary
Duration from incision to completion of graft fixation, recorded in minutes for each eye.
Measured: Time Frame: At surgery (intraoperative)
Early recurrence (clinical evidence of fibrovascular regrowth at limbus) -
Presence or absence of early fibrovascular regrowth onto cornea at 1 month (noting that longer follow-up is required for definitive recurrence rates).
Measured: Time Frame: 4 weeks (Month 1) postoperatively
Adverse events (type and severity) - Secondary (Safety)
All adverse events related to the procedure recorded and graded (e.g., infection, granuloma, graft loss), with details on management
Measured: Time Frame: Within 1 month postoperatively
Donor site epithelialization (complete: Y/N and time to healing in days) - Secondary
Presence of complete re-epithelialization of donor site confirmed clinically and by AS-OCT; record time (days) to complete healing.
Measured: Time Frame: Assessed weekly up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Sep 2025
- Primary completion15 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Pterygium, ASOCT, Conjunctival Autograft SurgeryStudies of the same condition, open and under way.
- More trials run by Minia 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
- Model description
- Randomized contralateral-eye design, where each patient contributed both eyes, one receiving sutured and the other sutureless graft fixation.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ramadan, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307820
- Sponsor's protocol ID
- 166072025
- Acronym
- ASOCT
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies regarding patient privacy and confidentiality, as well as restrictions based on ethical committee requirements. Data sharing may be reconsidered upon formal request and in compliance with all relevant regulations protecting participant information."
Publications
Natung T, et al. Sutureless, glue-less conjunctival autograft versus sutured autograft in primary pterygium surgery. PMC article. 2017
Mahajan S, et al. A Comparative Study of Suture-less and Glue-Free versus Sutured Conjunctival Autograft in Pterygium Surgery. Arch of Medical & Health Science. 2021
Aguilar-Gonzalez M, Espana-Gregori E, Pascual-Camps I, Gomez-Lechon-Quiros L, Peris-Martinez C. Prospective Study: Utility of Anterior Segment Optical Coherence Tomography to Identify Predictive Factors of Recurrence in Pterygium Surgery. J Clin Med. 2024 Aug 14;13(16):4769. doi: 10.3390/jcm13164769.
PubMed 39200911
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutureless Glueless Technique Versus Interrupted Suturing for Conjunctival Autograft Fixation After Primary Pterygium Excision: Anterior Segment Optical Coherence Tomography (ASOCT) Study
- ClinicalTrials.gov ID
- NCT07307820
- Acronym / sponsor ID
- ASOCT / 166072025
- Keywords
- Primary pterygium, ASOCT, conjunctival autograft surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 29 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 aims to compare the clinical and Anterior segment optical coherence tomography (ASOCT) outcomes between sutured and sutureless conjunctival autograft fixation techniques in the management of primary pterygium.
A total of 30 patients with bilateral primary pterygia were included. Each patient underwent pterygium excision in both eyes: one eye received graft fixation using interrupted 10-0 nylon sutures, while the fellow eye received sutureless fixation. Allocation of technique between eyes was randomized.
All surgeries were performed by the same surgeon, and patients were followed up weekly for one month. Parameters assessed included graft thickness, interface reflectivity, gutter size, conjunctival congestion, donor site healing, and postoperative discomfort using a visual analogue scale.
The study evaluates which fixation method provides faster healing, better cosmetic results, and fewer complications such as graft slippage or recession, especially in relation to pterygium size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized contralateral-eye design, where each patient contributed both eyes, one receiving sutured and the other sutureless graft fixation.
| Arm | Type | Receives |
|---|---|---|
| sutured conjunctival autograft fixation | Experimental | Procedure: sutured conjunctival autograft fixationconjunctival autograft secured with interrupted 10/0 nylon after pterygium exision |
| sutureless glueless conjunctival autograftfixation | Experimental | Procedure: Sutureless Conjunctival Autograft FixationConjunctival autograft placed without sutures, relying on natural adhesion and fibrin clot formation. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| sutured conjunctival autograft fixationAfter pterygium excision, a conjunctival autograft is secured in place using interrupted 10-0 nylon sutures to ensure graft stability and promote healing | Procedure or surgery | sutured conjunctival autograft fixation |
| Sutureless Conjunctival Autograft FixationFollowing pterygium excision, the conjunctival autograft is placed without sutures, relying on natural adhesion and fibrin clot formation to maintain graft position. | Procedure or surgery | sutureless glueless conjunctival autograftfixation |
Primary outcome
Graft stability: incidence of slippage or recession (%) - Secondary (Safety/Complication)
Time frame: Time Frame: Within 1 month postoperatively
Proportion of eyes with clinically significant graft slippage or marginal recession requiring intervention or observed during follow-up.
Patient-reported discomfort (VAS 0-10) - Secondary
Time frame: Time Frame: Day 1, Week 1, Week 2, Week 3, Week 4
Mean Visual Analogue Scale (0 = no discomfort to 10 = worst possible) recorded at each visit.
Cosmetic outcome - surgeon-rated score (0-10)
Time frame: Time Frame: 4 weeks (Month 1) postoperatively
Surgeon's cosmetic grading based on redness, graft contour and surface smoothness (0 = poor to 10 = excellent).
9 secondary outcomes
Interface reflectivity (qualitative grading: low/moderate/high)
Time frame: Time Frame: Week 1, Week 2, Week 3, Week 4
Change in central graft thickness (µm) -
Time frame: Baseline (Day 1) to Week 4
Mean central graft thickness measured by AS-OCT (µm)
Time frame: Time Frame: 4 weeks (Month 1) postoperatively
Conjunctival congestion score (0-3)
Time frame: Time Frame: Day 1, Week 1, Week 2, Week 3, Week 4
Gutter size at graft-host junction (µm)
Time frame: Time Frame: Week 1, Week 2, Week 3, Week 4
Operative time (minutes) - Secondary
Time frame: Time Frame: At surgery (intraoperative)
Early recurrence (clinical evidence of fibrovascular regrowth at limbus) -
Time frame: Time Frame: 4 weeks (Month 1) postoperatively
Adverse events (type and severity) - Secondary (Safety)
Time frame: Time Frame: Within 1 month postoperatively
Donor site epithelialization (complete: Y/N and time to healing in days) - Secondary
Time frame: Time Frame: Assessed weekly up to 4 weeks
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 29 Dec 2025.
- BackgroundNatung T, et al. Sutureless, glue-less conjunctival autograft versus sutured autograft in primary pterygium surgery. PMC article. 2017
- BackgroundMahajan S, et al. A Comparative Study of Suture-less and Glue-Free versus Sutured Conjunctival Autograft in Pterygium Surgery. Arch of Medical & Health Science. 2021
- Background: PubMed 39200911Aguilar-Gonzalez M, Espana-Gregori E, Pascual-Camps I, Gomez-Lechon-Quiros L, Peris-Martinez C. Prospective Study: Utility of Anterior Segment Optical Coherence Tomography to Identify Predictive Factors of Recurrence in Pterygium Surgery. J Clin Med. 2024 Aug 14;13(16):4769. doi: 10.3390/jcm13164769.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies regarding patient privacy and confidentiality, as well as restrictions based on ethical committee requirements. Data sharing may be reconsidered upon formal request and in compliance with all relevant regulations protecting participant information."
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sutured conjunctival autograft fixation and Sutureless Conjunctival Autograft Fixation in people with Primary Pterygium, ASOCT, Conjunctival Autograft Surgery, run by Minia 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?
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 29 Dec 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?
Graft stability: incidence of slippage or recession (%) - Secondary (Safety/Complication) (time frame: Time Frame: Within 1 month postoperatively). The study lists 3 primary outcomes in all. 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 NCT07307820, which also lists 3 linked publications.
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 29 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.