Pattern Laser Versus Conventional Laser in Diabetic Retinopathy
Single Session of Pattern Scanning Laser Versus Multiple Sessions of Conventional Laser for Panretinal Photocoagulation in Diabetic Retinopathy: Efficacy, Safety and Painfulness
1 other identifier
interventional
30
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2014
CompletedFirst Submitted
Initial submission to the registry
September 7, 2018
CompletedFirst Posted
Study publicly available on registry
September 14, 2018
CompletedSeptember 14, 2018
September 1, 2018
6 years
September 7, 2018
September 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
1 year
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)
1 day
Secondary Outcomes (1)
Satisfaction assessed by the VAS
1 day
Study Arms (2)
pattern scanning laser system Pascal
EXPERIMENTALconventional laser
ACTIVE COMPARATORInterventions
pattern scanning laser system Pascal given in a single-session
Eligibility Criteria
You may qualify if:
- Diabetic retinopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31310626DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2018
First Posted
September 14, 2018
Study Start
January 1, 2008
Primary Completion
December 31, 2013
Study Completion
January 25, 2014
Last Updated
September 14, 2018
Record last verified: 2018-09