Pattern Laser Versus Conventional Laser in Diabetic Retinopathy

Not Applicable

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Device: conventional laser; Device: lasercoagulation by Pascal system

• Registration Number: NCT03672656
• Lead Sponsor: University Hospital Ostrava

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2013-12-31
• Study Completion: 2014-01-25
• Status Verified: 2018-09
• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-13
• Last Update Submitted: 2018-09-13
• Study First Posted: 2018-09-14
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diabetic retinopathy

Exclusion Criteria

• No

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional laser	conventional laser	-
pattern scanning laser system Pascal	lasercoagulation by Pascal system	-

Primary Outcome Measures

Name	Time	Method
Clinical efficiency - progression of diabetic retinopathy, scored by calculating of microaneurisms and intraretinal hemorrhages	1 year	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	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

Name	Time	Method
Satisfaction assessed by the VAS	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