NCT01024257

Brief Summary

PURPOSE: To affirm the effectiveness and complication rate of postoperative single-dose beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial. METHODS AND MATERIALS: This trial was designed as a prospective, randomized, single center study. Surgery was performed in all cases according to the conjunctival autograft technique. One thousand and four patients with 108 pterygia were postoperatively randomized to either beta-RT or observation. In the case of beta-RT, a (90) Sr eye applicator was used to deliver 1000 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. RESULTS: Between February 2007 and September 2008, 104 eyes with primary pterygium were operated on according to the trial protocol. Additional treatment was performed within 24 hours postoperatively. Four patients were lost to follow-up, resulting in 104 patients who could be analyzed. In the 54 eyes randomized to receive beta-RT, 5 relapses occurred compared with 8 recurrences in the 50 eyes that no received RT, for a crude control rate of 90.7 % vs. 84 %, respectively. At a mean follow-up of 9 months (range 4- 18), major treatment complications had not been observed . CONCLUSION: Single-dose beta-RT of 1000cGy after conjunctival autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary pterygium recurrence.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

First QC Date

November 30, 2009

Last Update Submit

December 1, 2009

Conditions

Pterygium

Keywords

beta-irradiation;conjunctival autograft;pterygium;recurrence; clinical trial

Study Arms (2)

conjunctival autograft plus beta-irradiation

EXPERIMENTAL
Radiation: beta-irradiation

conjunctival autograft

ACTIVE COMPARATOR
Procedure: conjunctival autograft

Interventions

beta-irradiationRADIATION
conjunctival autograft plus beta-irradiation
conjunctival autograftPROCEDURE
conjunctival autograft

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fresh pterygium without previous treatment.
  • Adult patients with age higher than 18 years.

You may not qualify if:

  • Diagnosis of glaucoma.
  • Previous treatment of pterygium.
  • Patients with age less than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustavo Viani Arruda

Marília, Saop Paulo, 17516660, Brazil

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations

BR(1)