Pattern Laser Versus Conventional Laser in Diabetic Retinopathy

September 13, 2018 updated by: University Hospital Ostrava

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic retinopathy

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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)
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2008

Primary Completion (ACTUAL)

December 31, 2013

Study Completion (ACTUAL)

January 25, 2014

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (ACTUAL)

September 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-OCNI-Pascal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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