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

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 Overview

• Status: Completed
• Conditions: Primary Pterygium, ASOCT, Conjunctival Autograft Surgery
• Intervention / Treatment: Procedure: sutured conjunctival autograft fixation; Procedure: Sutureless Conjunctival Autograft Fixation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minia Governorate
    • Minya, Minia Governorate, Egypt, 61511
      • Minia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sutured conjunctival autograft fixation; conjunctival autograft secured with interrupted 10/0 nylon after pterygium exision	Procedure: sutured conjunctival autograft fixation; After pterygium excision, a conjunctival autograft is secured in place using interrupted 10-0 nylon sutures to ensure graft stability and promote healing
Experimental: sutureless glueless conjunctival autograftfixation; Conjunctival autograft placed without sutures, relying on natural adhesion and fibrin clot formation.	Procedure: Sutureless Conjunctival Autograft Fixation; Following pterygium excision, the conjunctival autograft is placed without sutures, relying on natural adhesion and fibrin clot formation to maintain graft position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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: 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: 4 weeks (Month 1) postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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.	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: 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: 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: 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: 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: 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: 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: Assessed weekly up to 4 weeks

Collaborators and Investigators

• Sponsor: Minia University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): November 15, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Primary pterygium, ASOCT, conjunctival autograft surgery
• Other Study ID Numbers: 166072025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No