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

Minia University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Pterygium, ASOCT, Conjunctival Autograft Surgery

Interventions

Eligibility

Sex: ALLMax age: 60 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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).

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

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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

Time frame: 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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes