NCT00370279

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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
Last Updated

June 26, 2008

Status Verified

June 1, 2008

First QC Date

August 30, 2006

Last Update Submit

June 25, 2008

Conditions

Pseudophakic Retinal DetachmentAphakic Retinal Detachment

Keywords

Pseudophakic retinal detachment,Aphakic retinal detachment,Scleral buckling,Primary vitrectomy,Proliferative vitreoretinopathy

Outcome Measures

Primary Outcomes (2)

  • Retinal reattachment rate

  • Visual acuity

Secondary Outcomes (5)

  • Proliferative vitreoretinopathy

  • Macular Pucker

  • Anisometropia

  • Choroidal detachment

  • Reoperation

Study Arms (4)

1

ACTIVE COMPARATOR

scleral buckling

Procedure: scleral buckling, primary vitrectomy

2

ACTIVE COMPARATOR

Primary vitrectomy without encircling band

Procedure: scleral buckling, primary vitrectomy

3

ACTIVE COMPARATOR

Primary vitrectomy with encircling band

Procedure: scleral buckling, primary vitrectomy

4

ACTIVE COMPARATOR

Triamcinolone assisted vitrectomy

Procedure: scleral buckling, primary vitrectomy

Interventions

scleral buckling, primary vitrectomyPROCEDURE

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

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Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • PVR grade C
  • History of surgery for RD
  • Signs of diabetic retinopathy, AMD, glaucoma and macular hole
  • History of ocular trauma
  • Giant retinal tear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamid Ahmadieh, MD

Tehran, Tehran Province, 16666, Iran

RECRUITING

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative

Interventions

Scleral Buckling

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hamid Ahmadieh, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamid Ahmadieh, MD

CONTACT

+98 21 22585952hahmadieh@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

September 1, 2005

Last Updated

June 26, 2008

Record last verified: 2008-06

Locations

IR(1)