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Pattern Laser Versus Conventional Laser in Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT03672656
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

Study Description
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Brief Summary:

Purpose: To evaluate the clinical efficiency, safety and painfulness of retinal laser photocoagulation employing a pattern scanning laser system Pascal given in a single-session versus conventional laser multiple-session treatment of the same patient with diabetic retinopathy.

Methods: The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic, Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on one eye using the multispot panretinal photocoagulation given in a single-session system Pascal (SSP) (OptiMedica, Santa Clara, California). On the other eye laser treatment was carried out by the classic conventional multiple-session method (MSM).


Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Device: lasercoagulation by Pascal system Device: conventional laser Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Session of Pattern Scanning Laser Versus Multiple Sessions of Conventional Laser for Panretinal Photocoagulation in Diabetic Retinopathy: Efficacy, Safety and Painfulness
Actual Study Start Date : January 1, 2008
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : January 25, 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: pattern scanning laser system Pascal Device: lasercoagulation by Pascal system
pattern scanning laser system Pascal given in a single-session
Active Comparator: conventional laser Device: conventional laser
conventional laser multiple-session treatment


Outcome Measures
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Primary Outcome Measures :
  1. Clinical efficiency - progression of diabetic retinopathy, scored by calculating of microaneurisms and intraretinal hemorrhages [ Time Frame: 1 year ]
    progression of diabetic retinopathy after pattern PASCAL laser versus conventional laser. Each item is scored by calculating of microaneurisms and intraretinal hemorrhages

  2. Pain assessed by NRS [ Time Frame: 1 day ]
    painfulness of pattern PASCAL laser versus conventional laser Each item is scored 0-10 (0 - no pain, 10 - pain as bad as can be)


Secondary Outcome Measures :
  1. Satisfaction assessed by the VAS [ Time Frame: 1 day ]
    subjective satisfaction of the patient on dog 0 to 4 0 - not satisfied, 4 - very satisfied after pattern PASCAL laser versus conventional laser


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic retinopathy

Exclusion Criteria:

  • No
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03672656    
Other Study ID Numbers: FNO-OCNI-Pascal
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Ostrava:
diabetic retinopathy
patterns
low time of impulse
Pascal
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases