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Completed

NCT Number: NCT04436900

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammad Sadegh Bagheri Baghdasht

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. RNFL

    Time frame: up to 30 days

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

  3. BCVA

    Time frame: up to 3 months

    best corrected visual acuity which measured by SD-OCT

  4. Retinal thickness in the central part of Fovea

    Time frame: up to 30 days

    Measured by SD-OCT

  5. Choroid thickness in the central part of Fovea

    Time frame: up to 30 days

    Measured by EDI-OCT

  6. Physical examination of PDR

    Time frame: up to 3 months

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

  7. Contrast sensitivity

    Time frame: up to 3 months

    Contrast sensitivity which measured by Melbourne edge test

  8. Angiography with fluorescein

    Time frame: up to 3 months

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

Sponsors and collaborators

Lead sponsor

Baqiyatallah Medical Sciences University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2020
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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