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

Pseudophakic Retinal Detachment Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00370279
• Other study ID #: 8405
• Status: Recruiting
• Phase: Phase 3
• First received: August 30, 2006
• Last updated: June 25, 2008
• Start date: September 2005

Study information

• Verified date: June 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: Hamid Ahmadieh, MD
• Phone: +98 21 22585952
• Email: hahmadieh[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphakic Retinal Detachment
• Dissociative Disorders
• Pseudophakic Retinal Detachment
• Retinal Detachment

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hamid Ahmadieh, MD	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal reattachment rate
Primary	Visual acuity
Secondary	Proliferative vitreoretinopathy
Secondary	Macular Pucker
Secondary	Anisometropia
Secondary	Choroidal detachment
Secondary	Reoperation