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Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03377348
Enrollment
30
Registered
2017-12-19
Start date
2017-12-01
Completion date
2019-12-01
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pterygium

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 .

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* primary pterygium.

Exclusion criteria

* preexisting glaucoma . * patient with family history of glaucoma

Design outcomes

Primary

MeasureTime frameDescription
the rate of recurrence by grading system of Prabhasawat6 monthsit 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026