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PASCAL Laser Platform Produces Less Pain Responses Compared To Conventional Laser System

NCT02645383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-01-01

No results posted yet for this study

Summary

The aim of this study is to compare the severity of expressed pain scores in patients with PDR who underwent either PASCAL or conventional laser and to assess the association between patient characteristics and severity of pain.

Conditions

Interventions

DEVICE

PASCAL laser

A novel semi-automatic and multi-shot photocoagulator called as PASCAL (Pattern scan laser, Opti-Medica Corp., Santa Clara, California, USA) was introduced with a reduction in pulse duration of each laser spot from typical 100 ms down to 10-30 millisecond. Compared with the conventional laser, shorter pulses have been shown to significantly reduce the risk of damage to the adjacent retinal tissues. One eye was treated with PASCAL laser, the other was treated with conventional laser with 30 minutes resting intervals. To avoid a bias about orientation or becoming accustomed to laser procedure, PASCAL laser was performed in the first eyes in half of the patients (14 patients) randomly.

DEVICE

Conventional laser

Maintaining of good glycemic regulation and performing panretinal laser photocoagulation (PRP) with conventional laser device (ELLEX Integre, Adailade, Australia) when it is indicated are evidence based effective methods for proliferative diabetic retinopathy.One eye was treated with conventional laser, the other was treated with PASCAL laser with 30 minutes resting intervals. To avoid a bias about orientation or becoming accustomed to laser procedure, conventional laser was performed in the first eyes in half of the patients (14 patients) randomly.

Sponsors & Collaborators

  • Kocatepe University

    lead OTHER

Principal Investigators

  • Umit U Inan, M.D · Kocatepe University Medical School Department of Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-07-31
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02645383 on ClinicalTrials.gov