Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision

NCT06734663 | Not Yet Recruiting

• 1 other identifier: IRB
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to find out if a certain technique in pterygium excision surgery ,using no sutures, is better than the technique mostly used ,which uses sutures. Investigators aim to find out whether the no sutures technique provides better efficiency and patient satisfaction than the traditional approach. They predict that if this study provides evidence of the advantages of this technique over the one used, surgeons would be encouraged to use it instead. Because not only would the patient benefit, the surgeon also may save operative time and effort used in the technique which uses sutures.

Conditions

Pterygium of Conjunctiva and Cornea; Pterygium of Both Eyes; Pterygium

Keywords

pterygium surgery; sutureless pterygium; autologous blood; serum; pterygium excision using autologous blood in comparison to using sutures; new techniques in pterygium surgery

Outcome Measures

Primary Outcomes (1)

• to evaluate the rate of conjuctival graft displacement in pterygium excision and graft placement without sutures

  the most valuable aim in this comparative study is to document if the graft placed sutureless will remain in place.So, in each follow-up, graft is assessed in regards to placement.

  3 months

Study Arms (2)

pterygium excision using sutured technique

PLACEBO COMPARATOR

This represents the main used technique in pterygium surgery that we will compare the less familiar sutureless technique to. pterygium is surgically removed and conjuctival graft is placed using sutures

Procedure: Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision; Procedure: pterygium excision and conjuctival graft suturing

sutureless technique

ACTIVE COMPARATOR

this represents the experimented technique in which pterygium excision is done and the graft is placed sutureless.

Procedure: Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision; Procedure: pterygium excision and conjuctival graft placement by autologous blood

Interventions

Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision PROCEDURE

Studies have concluded that pterygium surgical excision is the main treatment for pterygium. Pterygium excision with superior graft is the procedure followed most commonly at present. This is achieved by many methods, with the result differing from one method to another. The most important difference is the incidence of recurrence(4)But Varioustechniques such as Bare Sclera, Rotational Conjunctival Flap, Limbal Conjunctival Autograft, Amniotic Membrane Graft, and Free Conjunctival Autograft are also used for the removal of pterygium(3 ,4)Of the various possible alternative approaches, conjunctival autograft is usually preferred. Diverse methods for grafting with sutures, glue or autologous serum from the recipient bed are in use (5,6). Many adjunctive therapies like mitomycin C, corticosteroids, thiotepa, interferon-alpha- 2b, beta irradiation, 5-FU are being used to decrease the risk of recurrence after surgical removal of pterygium.

pterygium excision using sutured technique; sutureless technique

pterygium excision and conjuctival graft suturing PROCEDURE

pterygium is surgically removed, and a conjuctival graft is placed on bare sclera using sutures to surrounding conjuctiva.

pterygium excision using sutured technique

pterygium excision and conjuctival graft placement by autologous blood PROCEDURE

pterygium is surgically removed and a conjuctival graft is placed on bare sclera on which the patient's blood remains. the graft is left without sutures, adhering only by autologous blood.

sutureless technique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged between 18-60 years old.
• Patients diagnosed with primary Pterygium (Grades 1-4)

You may not qualify if:

• Patients unable to offer viable consent
• Patients with other significant ocular surface diseases, bleeding disorders, or systemic conditions affecting wound healing.)
• Recurrent pterygium
• Combined ocular surgery

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Ophthalmology department Assiut university

Asyut, Asyut Governorate, Egypt

Location

Ophthalmology department, Assiut University hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Pterygium Of Conjunctiva And Cornea; Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Central Study Contacts

Amal Resident Doctor

CONTACT

+20 1000247100; amaalsheriff@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Ophthalmology department, Faculty of medicine, Assiut University

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: December 16, 2024
• Study Start: December 15, 2024
• Primary Completion: April 20, 2025
• Study Completion: September 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (2)