Surgical Management of Pseudophakic and Aphakic Retinal Detachment; a Randomized Clinical Trial

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00370279
• Collaborator: (none)
• Location: 1
• Arms: 4

Study Details

Study Description

Brief Summary

To compare the visual and anatomical outcomes and complications of four surgical techniques (1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy) for management of pseudophakic and aphakic retinal detachment

Condition or Disease	Intervention/Treatment	Phase
Pseudophakic Retinal Detachment; Aphakic Retinal Detachment	Procedure: scleral buckling, primary vitrectomy	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 scleral buckling	Procedure: scleral buckling, primary vitrectomy; Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy
Active Comparator: 2 Primary vitrectomy without encircling band	Procedure: scleral buckling, primary vitrectomy; Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy
Active Comparator: 3 Primary vitrectomy with encircling band	Procedure: scleral buckling, primary vitrectomy; Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy
Active Comparator: 4 Triamcinolone assisted vitrectomy	Procedure: scleral buckling, primary vitrectomy; Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy

Outcome Measures

Primary Outcome Measures

1. Retinal reattachment rate []

2. Visual acuity []

Secondary Outcome Measures

1. Proliferative vitreoretinopathy []

2. Macular Pucker []

3. Anisometropia []

4. Choroidal detachment []

5. Reoperation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cases of pseudophakic and aphakic retinal detachment with PVR grade A or B

Exclusion Criteria:

• PVR grade C

• History of surgery for RD

• Signs of diabetic retinopathy, AMD, glaucoma and macular hole

• History of ocular trauma

• 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: NCT00370279
• Other Study ID Numbers: 8405
• First Posted: Aug 31, 2006
• Last Update Posted: Jun 26, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Pseudophakic retinal detachment,; Aphakic retinal detachment,; Scleral buckling,; Primary vitrectomy,; Proliferative vitreoretinopathy
• Additional relevant MeSH terms: Retinal Detachment; Dissociative Disorders

Study Results

No Results Posted as of Jun 26, 2008