CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
PASCAL laser +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02645383
NCT02645383N/ACompleted

An Observational Prospective Study of Comparing Pain Responses With Pattern Laser Platform and Conventional Laser System During the Panretinal Photocoagulation in Proliferative Diabetic Retinopathy

Kocatepe University·interventional·Posted Jan 1, 2016·Updated Jan 1, 2016

In Brief

A clinical study evaluating PASCAL laser and Conventional laser for Diabetic Retinopathy. Completed, enrolled 30 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 1, 2016
Enrollment StartMay 1, 2014
Primary CompletionJul 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.5 years ago

Interventions

PASCAL laserdevice

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.

Conventional laserdevice

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.