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

NCT ID: NCT06734663

Last Updated: 2024-12-16

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pterygium of Conjunctiva and Cornea Pterygium of Both Eyes Pterygium

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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pterygium excision using sutured technique

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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

Intervention Type PROCEDURE

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

sutureless technique

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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 placement by autologous blood

Intervention Type 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.

Interventions

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

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.

Intervention Type PROCEDURE

pterygium excision and conjuctival graft suturing

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

Intervention Type PROCEDURE

pterygium excision and conjuctival graft placement by autologous blood

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amal Sherif Sayed Abdelrehim

Resident at Ophthalmology department, Faculty of medicine, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmology department Assiut university

Asyut, Asyut Governorate, Egypt

Site Status

Ophthalmology department, Assiut University hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Amal Resident Doctor

Role: CONTACT

Phone: +20 1000247100

Email: [email protected]

Facility Contacts

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amal sherif, Resident

Role: primary

Other Identifiers

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IRB

Identifier Type: -

Identifier Source: org_study_id