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NCT Number: NCT06734663

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

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.

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Key information

Conditions

Pterygium of Conjunctiva and Cornea Conjunctival Diseases Eye Diseases Pterygium Pterygium of Both Eyes

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology department Assiut university, Asyut, Asyut Governorate, Egypt

About this study

This study is a comparative interventional study, in which patients are assigned into two groups comparable in age, gender, and general condition. The first group consists of patients with primary pterygium who will undergo surgery in a traditional approach in which the pterygium is surgically removed and after which a conjuctival graft is placed on the exposed sclera and sutured to the surrounding conjuctiva; in comparison, patients of the second group undergo pterygium excision in a similar matter initially.But the conjuctival graft is placed on the exposed sclera without suturing it to the nearby conjuctiva; instead, the graft remains in place using the patient's autologous blood. Fresh blood is left under the graft, while the surgeon merely compresses the graft for a few minutes. The aim of this study is to reach a conclusion as to which technique is more beneficial, to the patient and surgeon.

Patients included in this study must have primary pterygium, no known hematological condition, and full consent to the study. Surgery time is recorded to compare the effect of avoiding sutures on the surgeon's speed. After that, Patients are followed up in documented certain intervals post-operative, to assess graft displacement, signs of inflammation, signs of bleeding under graft, and patients' overall discomfort and satisfaction.

Finally, the two groups are compared with all factors taken into consideration. The ultimate target is to document evidence of the efficiency of the sutureless technique and endorse its application by Ophthalmologists elsewhere.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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 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 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.

Primary outcomes

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

Time frame: 3 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amal Resident Doctor

CONTACT

[email protected]

+20 1000247100

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 16, 2024
Registry last updated: Dec 16, 2024

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.

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Completed