Back to resultsPattern Laser Versus Conventional Laser in Diabetic Retinopathy
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lasercoagulation by Pascal system
conventional laser
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, patterns, low time of impulse, Pascal
Eligibility Criteria
Inclusion Criteria:
- Diabetic retinopathy
Exclusion Criteria:
- No
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pattern scanning laser system Pascal
conventional laser
Arm Description
Outcomes
Primary Outcome Measures
Clinical efficiency - progression of diabetic retinopathy, scored by calculating of microaneurisms and intraretinal hemorrhages
progression of diabetic retinopathy after pattern PASCAL laser versus conventional laser. Each item is scored by calculating of microaneurisms and intraretinal hemorrhages
Pain assessed by NRS
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
Satisfaction assessed by the VAS
subjective satisfaction of the patient on dog 0 to 4 0 - not satisfied, 4 - very satisfied after pattern PASCAL laser versus conventional laser
Full Information
NCT ID
NCT03672656
First Posted
September 7, 2018
Last Updated
September 13, 2018
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT03672656
Brief Title
Pattern Laser Versus Conventional Laser in Diabetic Retinopathy
Official Title
Single Session of Pattern Scanning Laser Versus Multiple Sessions of Conventional Laser for Panretinal Photocoagulation in Diabetic Retinopathy: Efficacy, Safety and Painfulness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2008 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
January 25, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
diabetic retinopathy, patterns, low time of impulse, Pascal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pattern scanning laser system Pascal
Arm Type
Experimental
Arm Title
conventional laser
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
lasercoagulation by Pascal system
Intervention Description
pattern scanning laser system Pascal given in a single-session
Intervention Type
Device
Intervention Name(s)
conventional laser
Intervention Description
conventional laser multiple-session treatment
Primary Outcome Measure Information:
Title
Clinical efficiency - progression of diabetic retinopathy, scored by calculating of microaneurisms and intraretinal hemorrhages
Description
progression of diabetic retinopathy after pattern PASCAL laser versus conventional laser. Each item is scored by calculating of microaneurisms and intraretinal hemorrhages
Time Frame
1 year
Title
Pain assessed by NRS
Description
painfulness of pattern PASCAL laser versus conventional laser Each item is scored 0-10 (0 - no pain, 10 - pain as bad as can be)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Satisfaction assessed by the VAS
Description
subjective satisfaction of the patient on dog 0 to 4 0 - not satisfied, 4 - very satisfied after pattern PASCAL laser versus conventional laser
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic retinopathy
Exclusion Criteria:
No
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31310626
Citation
Nemcansky J, Stepanov A, Nemcanska S, Masek P, Langrova H, Studnicka J. Single session of pattern scanning laser versus multiple sessions of conventional laser for panretinal photocoagulation in diabetic retinopathy: Efficacy, safety and painfulness. PLoS One. 2019 Jul 16;14(7):e0219282. doi: 10.1371/journal.pone.0219282. eCollection 2019.
Results Reference
derived
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Pattern Laser Versus Conventional Laser in Diabetic Retinopathy
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