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

NCT ID: NCT00370279

Last Updated: 2008-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Pseudophakic Retinal Detachment Aphakic Retinal Detachment

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

scleral buckling

Group Type ACTIVE_COMPARATOR

scleral buckling, primary vitrectomy

Intervention Type PROCEDURE

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

2

Primary vitrectomy without encircling band

Group Type ACTIVE_COMPARATOR

scleral buckling, primary vitrectomy

Intervention Type PROCEDURE

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

3

Primary vitrectomy with encircling band

Group Type ACTIVE_COMPARATOR

scleral buckling, primary vitrectomy

Intervention Type PROCEDURE

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

4

Triamcinolone assisted vitrectomy

Group Type ACTIVE_COMPARATOR

scleral buckling, primary vitrectomy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Hamid Ahmadieh, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

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Hamid Ahmadieh, MD

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Hamid Ahmadieh, MD

Role: CONTACT

Phone: +98 21 22585952

Email: [email protected]

Facility Contacts

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Hamid Ahmadieh, MD

Role: primary

Other Identifiers

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8405

Identifier Type: -

Identifier Source: org_study_id