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OpenTrials
Completed

NCT Number: NCT02816073

Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

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

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Lasers Retinal Diseases Treatment Outcome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pan-retinal photocoagulation using pattern scanning laser

Device

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

Primary outcomes

  1. Regression of neovascularization

    Time frame: 3 months

    Fluorescein angiogram assessment by independent observer

Secondary outcomes

  1. Activity of neovascularization

    Time frame: 3 months

    Descriptive analysis of fundus fluorescein angiogram by independent observer into 4 categories: no leakage, reduced leakage, same leakage, increased leakage

  2. Best corrected visual acuity

    Time frame: 1 week, 1 month, 3 months, 6 months

  3. Complications

    Time frame: 1 week, 1 month, 3 months, 6 months

    choroidal detachment, exudative retinal detachment, retinal breaks

  4. Central foveal thickness

    Time frame: 1 week

    Measured by spectral domain optical coherence tomography (Heidelberg Spectralis)

  5. Retreatment rate

    Time frame: 6 months

    Patients requiring retreatment with pan-retinal photocoagulation

Sponsors and collaborators

Lead sponsor

United Christian Hospital

Other

Collaborators

  • The University of Hong Kong

Registry information

Official study title

Single-session Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy - a Randomized Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2016
First posted
Jun 28, 2016
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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