An interventional study of Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision and pterygium excision and conjuctival graft suturing in Pterygium of Conjunctiva and Cornea, Pterygium of Both Eyes and Pterygium, sponsored by Assiut University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Assiut University · Not applicable, Interventional, and Other
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.
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.
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 93 interventional studies indexed under Pterygium.
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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
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
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 is surgically removed, and a conjuctival graft is placed on bare sclera using sutures to surrounding conjuctiva.
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.
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.
Time frame: 3 months
Plan to share: Yes
Supporting information: Study protocol
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