Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03377348

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pterygium	Procedure: intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Use of Intraoperative Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Bare Scleral Pterygium Excision

Actual Study Start Date :

Dec 1, 2017

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

primary pterygium.

Exclusion Criteria:

preexisting glaucoma .
patient with family history of glaucoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaa M. Abdelhafez	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Alaa Abdelhafez, Master Degree, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alaa Mohamed Abdelhafez, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03377348

Other Study ID Numbers:

First Posted:

Dec 19, 2017

Last Update Posted:

Feb 23, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pterygium

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Study Results

No Results Posted as of Feb 23, 2021