Skip to main content
Clinical Trials/NCT04436900
NCT04436900
Completed
Not Applicable

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

Baqiyatallah Medical Sciences University1 site in 1 country20 target enrollmentApril 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Baqiyatallah Medical Sciences University
Enrollment
20
Locations
1
Primary Endpoint
Life Quality
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 10, 2018
End Date
April 10, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Baqiyatallah Medical Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Mohammad Sadegh Bagheri Baghdasht

Principal Investigator

Baqiyatallah Medical Sciences University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

RNFL

Time Frame: up to 30 days

retinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)

Retinal thickness in the central part of Fovea

Time Frame: up to 30 days

Measured by SD-OCT

Choroid thickness in the central part of Fovea

Time Frame: up to 30 days

Measured by EDI-OCT

BCVA

Time Frame: up to 3 months

best corrected visual acuity which measured by SD-OCT

Contrast sensitivity

Time Frame: up to 3 months

Contrast sensitivity which measured by Melbourne edge test

Angiography with fluorescein

Time Frame: up to 3 months

By injecting fluorescein into the vein and then taking an X-ray to diagnose PDR

Physical examination of PDR

Time Frame: up to 3 months

An eye exam performed by an ophthalmologist will determine if there is retinopathy

Study Sites (1)

Loading locations...

Similar Trials