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Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

Primary Purpose

Diabetic Retinopathy, Lasers, Treatment Outcome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pan-retinal photocoagulation using pattern scanning laser
Sponsored by
United Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1,700

    2,500

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Regression of neovascularization
    Fluorescein angiogram assessment by independent observer

    Secondary Outcome Measures

    Activity of neovascularization
    Descriptive analysis of fundus fluorescein angiogram by independent observer into 4 categories: no leakage, reduced leakage, same leakage, increased leakage
    Best corrected visual acuity
    Complications
    choroidal detachment, exudative retinal detachment, retinal breaks
    Central foveal thickness
    Measured by spectral domain optical coherence tomography (Heidelberg Spectralis)
    Retreatment rate
    Patients requiring retreatment with pan-retinal photocoagulation

    Full Information

    First Posted
    June 21, 2016
    Last Updated
    June 28, 2016
    Sponsor
    United Christian Hospital
    Collaborators
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02816073
    Brief Title
    Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy
    Official Title
    Single-session Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy - a Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    United Christian Hospital
    Collaborators
    The University of Hong Kong

    4. Oversight

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Retinopathy, Lasers, Treatment Outcome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1,700
    Arm Type
    Active Comparator
    Arm Description
    Patients receive 1,700 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser
    Arm Title
    2,500
    Arm Type
    Active Comparator
    Arm Description
    Patients receive 2,500 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser
    Intervention Type
    Device
    Intervention Name(s)
    Pan-retinal photocoagulation using pattern scanning laser
    Intervention Description
    Patients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session
    Primary Outcome Measure Information:
    Title
    Regression of neovascularization
    Description
    Fluorescein angiogram assessment by independent observer
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Activity of neovascularization
    Description
    Descriptive analysis of fundus fluorescein angiogram by independent observer into 4 categories: no leakage, reduced leakage, same leakage, increased leakage
    Time Frame
    3 months
    Title
    Best corrected visual acuity
    Time Frame
    1 week, 1 month, 3 months, 6 months
    Title
    Complications
    Description
    choroidal detachment, exudative retinal detachment, retinal breaks
    Time Frame
    1 week, 1 month, 3 months, 6 months
    Title
    Central foveal thickness
    Description
    Measured by spectral domain optical coherence tomography (Heidelberg Spectralis)
    Time Frame
    1 week
    Title
    Retreatment rate
    Description
    Patients requiring retreatment with pan-retinal photocoagulation
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth KW Li, MBChB
    Organizational Affiliation
    United Christian Hospital; The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

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