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CompletedNCT03377348Updated Feb 23, 2021

Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision

An interventional study of intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision in Pterygium, sponsored by Assiut University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2021-02-23.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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 .

02

Conditions studied

  • Pterygium

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • primary pterygium.

Exclusion criteria

Exclusion Criteria:

  • preexisting glaucoma .
  • patient with family history of glaucoma
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    subconjunctival injection of triamcinolone acetonide

    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

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

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

05

What researchers measure

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.

    Time frame: 6 months

06

Study locations

1 site
  • Alaa M. Abdelhafez
    Assiut, Egypt
07

Registry details

Key details

Study ID
NCT03377348
Lead sponsor
Assiut University
Responsible party
Alaa Mohamed Abdelhafez (principal investigator, Assiut University) — Principal investigator
First posted
Dec 19, 2017
Start date
Dec 1, 2017
Primary completion
Aug 1, 2019
Completion
Dec 1, 2019
Last update
Feb 23, 2021

Study contacts

Alaa Abdelhafez, Master Degree
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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