Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00373282
• Collaborator: (none)
• Location: 1
• Duration (Months): 24

Study Details

Study Description

Brief Summary

To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR.

Condition or Disease	Intervention/Treatment	Phase
Proliferative Vitreoretinopathy	Drug: Triamcinolone acetonide	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2001
• Study Completion Date: Jun 1, 2003

Outcome Measures

Primary Outcome Measures

1. Single-operation retinal reattachment rate six []

2. months after surgery. []

Secondary Outcome Measures

1. Visual acuity []

2. Retinal reproliferation []

3. Intraocular pressure []

4. Early silicone oil emulsification []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cases of rhegmatogenous retinal detachment complicated by PVR grade C undergoing vitrectomy and silicone oil tamponade.

Exclusion Criteria:

• History of trauma

• Presence of diabetic retinopathy

• History of vein occlusion

• Giant retinal tear

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamid Ahmadieh,MD	Tehran		Iran, Islamic Republic of	16666

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

• Principal Investigator: Hamid Ahmadieh, MD, Ophthalmic Research Center of Shaheed Beheshti Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00373282
• Other Study ID Numbers: 8116
• First Posted: Sep 8, 2006
• Last Update Posted: Oct 12, 2006
• Last Verified: Aug 1, 2006

• Keywords provided by , ,: PVR; Retinal detachment; Silicone oil; Triamcinolone
• Additional relevant MeSH terms: Vitreoretinopathy, Proliferative; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate

Study Results

No Results Posted as of Oct 12, 2006