Clinical trial NCT06734663: Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision
Official title: Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: to evaluate the rate of conjuctival graft displacement in pterygium excision and graft placement without sutures
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ophthalmology department Assiut university
city: Assiut
country: Egypt
facility: Ophthalmology department, Assiut University hospital
Study officials:
References: