Back to resultsSurgical Management of Pseudophakic and Aphakic Retinal Detachment; a Randomized Clinical Trial
Primary Purpose
Pseudophakic Retinal Detachment, Aphakic Retinal Detachment
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
scleral buckling, primary vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pseudophakic Retinal Detachment focused on measuring Pseudophakic retinal detachment,, Aphakic retinal detachment,, Scleral buckling,, Primary vitrectomy,, Proliferative vitreoretinopathy
Eligibility Criteria
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
Sites / Locations
- Hamid Ahmadieh, MDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
scleral buckling
Primary vitrectomy without encircling band
Primary vitrectomy with encircling band
Triamcinolone assisted vitrectomy
Outcomes
Primary Outcome Measures
Retinal reattachment rate
Visual acuity
Secondary Outcome Measures
Proliferative vitreoretinopathy
Macular Pucker
Anisometropia
Choroidal detachment
Reoperation
Full Information
NCT ID
NCT00370279
First Posted
August 30, 2006
Last Updated
June 25, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00370279
Brief Title
Surgical Management of Pseudophakic and Aphakic Retinal Detachment; a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudophakic Retinal Detachment, Aphakic Retinal Detachment
Keywords
Pseudophakic retinal detachment,, Aphakic retinal detachment,, Scleral buckling,, Primary vitrectomy,, Proliferative vitreoretinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
scleral buckling
Arm Title
2
Arm Type
Active Comparator
Arm Description
Primary vitrectomy without encircling band
Arm Title
3
Arm Type
Active Comparator
Arm Description
Primary vitrectomy with encircling band
Arm Title
4
Arm Type
Active Comparator
Arm Description
Triamcinolone assisted vitrectomy
Intervention Type
Procedure
Intervention Name(s)
scleral buckling, primary vitrectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Retinal reattachment rate
Title
Visual acuity
Secondary Outcome Measure Information:
Title
Proliferative vitreoretinopathy
Title
Macular Pucker
Title
Anisometropia
Title
Choroidal detachment
Title
Reoperation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamid Ahmadieh, MD
Phone
+98 21 22585952
Email
hahmadieh@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamid Ahmadieh, MD
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Phone
+98 21 22585952
Email
hahmadieh@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Surgical Management of Pseudophakic and Aphakic Retinal Detachment; a Randomized Clinical Trial
We'll reach out to this number within 24 hrs