Pterygium
Conditions
Keywords
Conjunctival Autograft, Conjunctival Rotational Flap, Pterygium Recurrence
Brief summary
This study compares two surgical techniques for preventing the regrowth of a pterygium, a non-cancerous growth on the eye. After surgically removing the pterygium, surgeons will cover the area with either a flap of nearby tissue that is rotated into place (Rotational Flap) or with a free graft of tissue taken from under the upper eyelid (Autograft). The main goal is to see which method is better at preventing the pterygium from growing back over a 6-month period. A total of 342 patients with a primary pterygium will be randomly assigned to one of the two surgical groups.
Detailed description
This is a single-center, prospective, randomized controlled trial to be conducted at the Department of Ophthalmology, Saidu Group of Teaching Hospital, Swat. The study aims to compare the efficacy of the Conjunctival Rotational Flap versus the Conjunctival Autograft in reducing recurrence rates following primary pterygium excision. Adult patients aged 18-60 with primary pterygium will be enrolled. Participants will be randomly allocated into two groups: Group A (Conjunctival Rotational Flap) and Group B (Conjunctival Autograft). The primary outcome measure is the absence of clinical recurrence, defined as fibrovascular tissue crossing ≥ 1 mm onto the cornea, assessed at the 6-month postoperative follow-up visit via slit-lamp examination. Secondary outcomes may include operative time and postoperative complications. Data will be analyzed using SPSS version 23, with a p-value of ≤ 0.05 considered statistically significant.
Interventions
PROCEDUREConjunctival Rotational Flap
A surgical technique where adjacent conjunctival tissue, remaining partially attached, is rotated to cover the exposed sclera after pterygium excision.
PROCEDUREConjunctival Autograft
A surgical technique where a free graft of conjunctiva is harvested from the superior bulbar conjunctiva and sutured or glued over the scleral defect after pterygium excision
Sponsors
College of Physicians and Surgeons Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to one of two parallel groups for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* • Age 18-60 * Either gender * Primary pterygium
Exclusion criteria
* • Collagen vascular disease * Autoimmune disorders * Pregnancy * Ocular surface infection * Previous limbal surgery * Recurrent or pseudo-pterygium * Ocular trauma * Corneal opacity/degeneration'
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pterygium Recurrence Rate | 6 months postoperatively | Absence of clinical recurrence, defined as a quiet ocular surface with no fibrovascular regrowth ≥ 1 mm onto the cornea, as measured by slit-lamp examination. |
Contacts
Primary ContactMuhammad Iqbal, MBBS
Outcome results
None listed