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NCT03672656 Clinical Trial

Pattern Laser Versus Conventional Laser in Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:
Single Session of Pattern Scanning Laser Versus Multiple Sessions of Conventional Laser for Panretinal Photocoagulation in Diabetic Retinopathy: Efficacy, Safety and Painfulness

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03672656
Other study ID # FNO-OCNI-Pascal
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2008
Est. completion date January 25, 2014

Study information
Verified date September 2018
Source University Hospital Ostrava
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 25, 2014
Est. primary completion date December 31, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Diabetic retinopathy

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• lasercoagulation by Pascal system
pattern scanning laser system Pascal given in a single-session
• conventional laser
conventional laser multiple-session treatment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Ostrava

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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 1 day
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