Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

NCT ID: NCT02816073

Last Updated: 2016-06-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-04-30

Brief Summary

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A randomized study to assess the safety and efficacy of single-session pan-retinal photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic retinopathy (PDR) - 1,700 shots vs 2,500 shots

Detailed Description

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Conditions

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Diabetic Retinopathy Lasers Treatment Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1,700

Patients receive 1,700 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser

Group Type ACTIVE_COMPARATOR

Pan-retinal photocoagulation using pattern scanning laser

Intervention Type DEVICE

Patients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session

2,500

Patients receive 2,500 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser

Group Type ACTIVE_COMPARATOR

Pan-retinal photocoagulation using pattern scanning laser

Intervention Type DEVICE

Patients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session

Interventions

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Pan-retinal photocoagulation using pattern scanning laser

Patients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All treatment-naïve patients with proliferative diabetic retinopathy (PDR) who attended our ophthalmic clinic from 1st December 2012 to 30th November

Exclusion Criteria

* significant media opacity affecting laser uptake (e.g. corneal opacity, mature cataract, dense vitreous haemorrhage)
* any pre-existing ocular disorders resulting in visual impairment (e.g. retinal degenerations, maculopathies, primary glaucoma and other optic neuropathies)
* those who received previous retinal laser treatment, intravitreal injections or intraocular surgeries
* clinically significant macular oedema on clinical examination.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

United Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chung-yee Chung

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth KW Li, MBChB

Role: PRINCIPAL_INVESTIGATOR

United Christian Hospital; The University of Hong Kong

Other Identifiers

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12-0079

Identifier Type: -

Identifier Source: org_study_id

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