Pterygium
Conditions
Keywords
Pterygium surgery, Sutureless glue free conjunctival autograft, Amniotic membrane graft.
Brief summary
Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical management techniques and high rate of post-operative recurrence. The investigators aim was to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in management of primary pterygium.
Detailed description
Design: Prospective randomized clinical trial comparative study. Setting: Department of ophthalmology, Al-Minia University Faculty of medicine, Egypt. Methods: The study included 150 eyes of 150 patients of primary pterygium. Twenty four to 74 years of age (mean 49 ± 12 years). Simple excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1), versus sutured free conjunctival autograft in 100 eyes of 100 patients (group 2).
Interventions
PROCEDURESutureless and glue free limbal conjunctival autograft
Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1)
PROCEDURESutured limbal conjunctival autograft
Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutured limbal conjunctival autograft in 100 eyes of 100 patients (group 2).
Sponsors
Minia University
Shaaban Elwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
24 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Patients complaining of primary pterygium with eye redness. Patients with pterygium threatening the visual axis.
Exclusion criteria
All cases not completed the follow up period for two years. Atrophic pterygium, pseudopterygium or double head pterygium.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | 24 months | The main postoperative primary outcomes measure the recurrence rate which was defined as fibrovascular proliferation invading the cornea more than 1.5 mm at the site of previously excised pterygium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative signs and symptoms | Third postoperative day,then weekly for one month | The secondary outcomes measure, postoperative pain, foreign body sensation, photophobia, hyperemia and chemosis. |
| Overall patient satisfaction | Third post-operative week | Overall satisfaction with the procedure 3 weeks post-operatively was recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The two groups were compared for overall satisfaction. |
| Complications | 24 months | Complications was recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperative | Calculation of operative time for each patient procedure |
| Gain in uncorrected visual acuity (UCVA) | First post-operative month | Gain in uncorrected visual acuity (UCVA) for each patient from the base line measurement |
Countries
Egypt
Outcome results
None listed