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Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision

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ClinicalTrials.gov Identifier: NCT03377348
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Alaa Mohamed Abdelhafez, 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.

Condition or disease Intervention/treatment Phase
Pterygium Procedure: intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. the rate of recurrence by grading system of Prabhasawat [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary pterygium.

Exclusion Criteria:

  • preexisting glaucoma .
  • patient with family history of glaucoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377348


Contacts
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Contact: Samir Yahia Saleh, MD 01003304320 Drsamiryahia@gmail.com
Contact: Abdelslam Abdallah, MD 01001099470 salamoph@yahoo.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Alaa Mohamed Abdelhafez, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03377348     History of Changes
Other Study ID Numbers: TIP
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Pterygium
Conjunctival Diseases
Eye Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action