Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision

NCT03377348 | Completed

• 1 other identifier: TIP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

• the rate of recurrence by grading system of Prabhasawat

  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.

  6 months

Study Arms (1)

subconjunctival injection of triamcinolone acetonide

OTHER

intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision

Procedure: intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision

Interventions

intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision PROCEDURE

intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision

subconjunctival injection of triamcinolone acetonide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• primary pterygium.

You may not qualify if:

• preexisting glaucoma .
• patient with family history of glaucoma

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Alaa M. Abdelhafez

Asyut, Egypt

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Officials

• Alaa Abdelhafez, Master Degree

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 19, 2017
• Study Start: December 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

EG (1)