Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision

Not Applicable

Completed

• Conditions: Pterygium

• Registration Number: NCT03377348
• Lead Sponsor: Assiut University

Brief Summary

Pterygium is characterized by encroachment of a fleshy fibrovascular tissue from the bulbar conjunctiva on to the cornea. Although previously thought to be a solely degenerative disease, a new evidence has demonstrated the role of cell proliferation and inflammation in the pathogenesis of pterygium , and also by the clinical data that steroids are beneficial in halting progression of impending recurrent pterygium . Many techniques have been developed for pterygium surgery over time. The simple method of removing the head and body of pterygium and leaving the sclera uncovered, the so-called bare-sclera technique, has been associated with high recurrence rates of 32-88% . To reduce the recurrence rate after pterygium surgery with a bare-sclera technique, various adjunctive modalities have been used such as chemical agents including mitomycin C , 5-fluorouracil . Furthermore, when removal of pterygium is accompanied with a graft, such as conjunctival autograft or amniotic membrane transplantation , lower recurrence rates have been achieved . However, it remains unclear why the bare sclera technique has poorer outcome with higher recurrence rate than other procedures.

Detailed Description

One of the factors that may have a role in the outcome of pterygium surgery is postoperative conjunctival inflammation , treatment of which has been demonstrated to improve the final outcome . It has been shown that persistent conjunctival inflammation around the surgical site after pterygium surgery is present in 31-84% of cases with amniotic membrane transplantation, and in 15% of eyes with conjunctival autograft . However, the rate of conjunctival inflammation after pterygium surgery with a bare-sclera technique has not been reported in literature . Also, it has been suggested that higher recurrence rate after pterygium with amniotic membrane transplantation compared with conjunctival autograft may be due to higher rate of postoperative conjunctival inflammation . Therefore, it may be speculated that higher recurrence rate after pterygium surgery with a bare-sclera technique is partly due to higher rate of postoperative conjunctival inflammation .

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-19
• Primary Completion: 2019-08-01
• Study Completion: 2019-12-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-20
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• primary pterygium.

Exclusion Criteria

• preexisting glaucoma .
• patient with family history of glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
the rate of recurrence by grading system of Prabhasawat	6 months	it is a grade to follow up the recurrence of pterygium which classifies pterygium excision outcome from grades 1 to 4: * Grade 1 : indicates a normal appearance of the operated site .; * Grade 2 : indicates the presence of fine episcleral vessels in the excised area, extending to the limbus but without any fibrous tissue .; * Grade 3 : indicates fibrovascular tissue in the excised area, reaching to the limbus but not invading the cornea and significant conjunctival recurrence .; * Grade 4: indicates a true corneal recurrence with fibrovascular tissue invading the cornea.

Trial Locations

Locations (1)

Alaa M. Abdelhafez; 🇪🇬 Assiut, Egypt