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Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision

Primary Purpose

Pterygium

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary pterygium.

Exclusion Criteria:

  • preexisting glaucoma .
  • patient with family history of glaucoma

Sites / Locations

  • Alaa M. Abdelhafez

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

subconjunctival injection of triamcinolone acetonide

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2017
Last Updated
February 20, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03377348
Brief Title
Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision
Official Title
Evaluation of the Use of Intraoperative Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Bare Scleral Pterygium Excision
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
subconjunctival injection of triamcinolone acetonide
Arm Type
Other
Arm Description
intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision
Intervention Type
Procedure
Intervention Name(s)
intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision
Intervention Description
intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision
Primary Outcome Measure Information:
Title
the rate of recurrence by grading system of Prabhasawat
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary pterygium. Exclusion Criteria: preexisting glaucoma . patient with family history of glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa Abdelhafez, Master Degree
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaa M. Abdelhafez
City
Assiut
Country
Egypt

12. IPD Sharing Statement

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Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision

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