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

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ClinicalTrials.gov Identifier: NCT00370279
Recruitment Status : Unknown
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : August 31, 2006
Last Update Posted : June 26, 2008
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

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 Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : September 2005

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U.S. FDA Resources

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



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


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370279


Contacts
Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com

Locations
Iran, Islamic Republic of
Hamid Ahmadieh, MD Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Hamid Ahmadieh, MD    +98 21 22585952    hahmadieh@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University

ClinicalTrials.gov Identifier: NCT00370279     History of Changes
Other Study ID Numbers: 8405
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: June 26, 2008
Last Verified: June 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
Pseudophakic retinal detachment,
Aphakic retinal detachment,
Scleral buckling,
Primary vitrectomy,
Proliferative vitreoretinopathy

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Mental Disorders
Retinal Diseases
Eye Diseases