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

NCT ID: NCT07307820

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Pterygium, ASOCT, Conjunctival Autograft Surgery

Keywords

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Primary pterygium, ASOCT, conjunctival autograft surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized contralateral-eye design, where each patient contributed both eyes, one receiving sutured and the other sutureless graft fixation.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sutured conjunctival autograft fixation

conjunctival autograft secured with interrupted 10/0 nylon after pterygium exision

Group Type EXPERIMENTAL

sutured conjunctival autograft fixation

Intervention Type 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 glueless conjunctival autograftfixation

Conjunctival autograft placed without sutures, relying on natural adhesion and fibrin clot formation.

Group Type EXPERIMENTAL

Sutureless Conjunctival Autograft Fixation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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).
Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Ramadan

lecturer of ophthalmolgy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia University Hospital

Minya, Minia Governorate, Egypt

Site Status

Countries

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Egypt

References

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Natung T, et al. Sutureless, glue-less conjunctival autograft versus sutured autograft in primary pterygium surgery. PMC article. 2017

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 39200911 (View on PubMed)

Other Identifiers

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166072025

Identifier Type: -

Identifier Source: org_study_id