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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370279
First received: August 30, 2006
Last updated: June 25, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Pseudophakic Retinal Detachment
Aphakic Retinal Detachment
Procedure: scleral buckling, primary vitrectomy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Retinal reattachment rate
  • Visual acuity

Secondary Outcome Measures:
  • Proliferative vitreoretinopathy
  • Macular Pucker
  • Anisometropia
  • Choroidal detachment
  • Reoperation

Study Start Date: September 2005
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Medical University
Investigators
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00370279     History of Changes
Other Study ID Numbers: 8405
Study First Received: August 30, 2006
Last Updated: June 25, 2008
Health Authority: Iran: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 20, 2014