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

NCT04436900 | Completed DMC

• 1 other identifier: IR.BMSU.REC.1396.455
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (8)

• Life Quality

  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

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

  up to 30 days

• BCVA

  best corrected visual acuity which measured by SD-OCT

  up to 3 months

• Retinal thickness in the central part of Fovea

  Measured by SD-OCT

  up to 30 days

• Choroid thickness in the central part of Fovea

  Measured by EDI-OCT

  up to 30 days

• Physical examination of PDR

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

  up to 3 months

• Contrast sensitivity

  Contrast sensitivity which measured by Melbourne edge test

  up to 3 months

• Angiography with fluorescein

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

  up to 3 months

Study Arms (1)

Intervention group

EXPERIMENTAL

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)

Interventions

Panretinal Photocoagulation (PRP) PROCEDURE

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead

Study Sites (1)

Mohammad Sadegh Bagheri Baghdasht

Tehran, 0, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 18, 2020
• Study Start: April 10, 2018
• Primary Completion: February 10, 2019
• Study Completion: April 10, 2019
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

IR (1)