Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy

June 16, 2020 updated by: Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University

The present study is a semi-experimental clinical trial that 20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms. The variables of contrast sensitivity, macula thickness under fovea , BCVA, the width of thyroid under fovea , RNFL thickness in the four areas around the disc, and the quality of life questionnaire of all patients were recorded at the beginning of the study.Retinal and choroid under fovea thickness and RNFL thickness were assessed in four areas, one week and one month after the end of treatment, and all the variables mentioned earlier were evaluated three months after PRP surgery.

This study is single group that the outcomes are compared before and after the intervention

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes Mellitus, Type 2 with PDR
  • Having conscious satisfaction

Exclusion Criteria:

  • Patients with a history of other eye diseases
  • Patients with a history of previous laser treatment
  • Patients with a history of injection of Anti-VGEF
  • Patients with Vitreous hemorrhage
  • Patients with Macula edema
  • Patients with myopia more than -3 diopters or hyperopiamore than +3 diopters

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms.
Procedure: Panretinal Photocoagulation (PRP)
PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life Quality
Time Frame: up to 3 months
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease Which is measured by a quality of life questionnaire
up to 3 months
RNFL
Time Frame: up to 30 days
retinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)
up to 30 days
BCVA
Time Frame: up to 3 months
best corrected visual acuity which measured by SD-OCT
up to 3 months
Retinal thickness in the central part of Fovea
Time Frame: up to 30 days
Measured by SD-OCT
up to 30 days
Choroid thickness in the central part of Fovea
Time Frame: up to 30 days
Measured by EDI-OCT
up to 30 days
Physical examination of PDR
Time Frame: up to 3 months
An eye exam performed by an ophthalmologist will determine if there is retinopathy
up to 3 months
Contrast sensitivity
Time Frame: up to 3 months
Contrast sensitivity which measured by Melbourne edge test
up to 3 months
Angiography with fluorescein
Time Frame: up to 3 months
By injecting fluorescein into the vein and then taking an X-ray to diagnose PDR
up to 3 months

Collaborators and Investigators

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

Sponsor

Baqiyatallah Medical Sciences University

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)

April 10, 2018

Primary Completion (ACTUAL)

February 10, 2019

Study Completion (ACTUAL)

April 10, 2019

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (ACTUAL)

June 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.BMSU.REC.1396.455

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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