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Comparison of Two Laser Therapy Methods for PDR

NCT ID: NCT01232179

Last Updated: 2010-11-02

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

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-05-31

Brief Summary

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Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal photocoagulation (PRP) which can improve the visual prognosis in this complication significantly. However , the treatment may also resulting adverse effects such as blurring of central vision, visual field constriction and disturbance in dark adaptation and contrast vision. Extended targeted retinal coagulation (TRP) to the ischemic areas may cause regression of the neovascularization while minimizing some of the risks and complication associated of treatment of PDR with these two methods.

Detailed Description

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Conditions

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Proiriftrative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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conventional prp

Group Type ACTIVE_COMPARATOR

conventional prp

Intervention Type PROCEDURE

pan retinal photocoagulation

targeted PRP

Group Type ACTIVE_COMPARATOR

targeted prp

Intervention Type PROCEDURE

1200-1600 spot in far periphery retin, anterior equator

Interventions

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conventional prp

pan retinal photocoagulation

Intervention Type PROCEDURE

targeted prp

1200-1600 spot in far periphery retin, anterior equator

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with PDR condidate for photocoagulation teraphy
* Pupil with dilatasion≥6mm
* without privious treatment with anti VEGF drugs 3months before study
* without privious vitroretinal sugery
* without privoius lasertraphy

Exclusion Criteria

* To have NVI cricteria with increase of inraocular pressure
* to have cataract or vitrus leakage which prevent lasertraphy
* pupil smaller that 6mm
* traditional retinal detachment
* privious treatment with anti VEGF drugs 3months before study
* privious PRP
* patient unable to get wide field FAG
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ophthalmic Research center

Locations

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Labbafinejad medical center

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Facility Contacts

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Masoud Soheilian, proffesor

Role: primary

References

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Nikkhah H, Ghazi H, Razzaghi MR, Karimi S, Ramezani A, Soheilian M. Extended targeted retinal photocoagulation versus conventional pan-retinal photocoagulation for proliferative diabetic retinopathy in a randomized clinical trial. Int Ophthalmol. 2018 Feb;38(1):313-321. doi: 10.1007/s10792-017-0469-7. Epub 2017 Feb 6.

Reference Type DERIVED
PMID: 28168567 (View on PubMed)

Other Identifiers

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88100

Identifier Type: -

Identifier Source: org_study_id