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Completed

NCT Number: NCT07307820

Sutureless Glueless Technique Versus Interrupted Suturing for Conjunctival Autograft Fixation After Primary Pterygium Excision: Anterior Segment Optical Coherence Tomography (ASOCT) 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.

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.

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Key information

Conditions

Primary Pterygium, ASOCT, Conjunctival Autograft Surgery

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University Hospital

Minya, Minia Governorate, 61511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

sutured conjunctival autograft fixation

Procedure

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 Fixation

Procedure

Following pterygium excision, the conjunctival autograft is placed without sutures, relying on natural adhesion and fibrin clot formation to maintain graft position.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. Interface reflectivity (qualitative grading: low/moderate/high)

    Time frame: Time Frame: Week 1, Week 2, Week 3, Week 4

    Qualitative grading of graft-host interface reflectivity on AS-OCT to indicate edema/fibrosis; images assessed by masked grader(s).

  2. Change in central graft thickness (µm) -

    Time frame: Baseline (Day 1) to Week 4

    Absolute and percent change in central graft thickness from Day 1 to Week 4 measured by AS-OCT.

  3. Mean central graft thickness measured by AS-OCT (µm)

    Time frame: Time Frame: 4 weeks (Month 1) postoperatively

    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.

  4. Conjunctival congestion score (0-3)

    Time frame: Time Frame: Day 1, Week 1, Week 2, Week 3, Week 4

    Clinician-graded vascular hyperemia (0 = none; 1 = mild; 2 = moderate; 3 = severe) at each visit.

  5. Gutter size at graft-host junction (µm)

    Time frame: Time Frame: Week 1, Week 2, Week 3, Week 4

    Linear measurement of the graft-host interface gap (gutter) by AS-OCT at each follow-up; reported as mean ± SD.

  6. Operative time (minutes) - Secondary

    Time frame: Time Frame: At surgery (intraoperative)

    Duration from incision to completion of graft fixation, recorded in minutes for each eye.

  7. Early recurrence (clinical evidence of fibrovascular regrowth at limbus) -

    Time frame: Time Frame: 4 weeks (Month 1) postoperatively

    Presence or absence of early fibrovascular regrowth onto cornea at 1 month (noting that longer follow-up is required for definitive recurrence rates).

  8. Adverse events (type and severity) - Secondary (Safety)

    Time frame: Time Frame: Within 1 month postoperatively

    All adverse events related to the procedure recorded and graded (e.g., infection, granuloma, graft loss), with details on management

  9. Donor site epithelialization (complete: Y/N and time to healing in days) - Secondary

    Time frame: Time Frame: Assessed weekly up to 4 weeks

    Presence of complete re-epithelialization of donor site confirmed clinically and by AS-OCT; record time (days) to complete healing.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Acronym: ASOCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.