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

Not Applicable
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Procedure: Panretinal Photocoagulation (PRP)
Registration Number
NCT04436900
Lead Sponsor
Baqiyatallah Medical Sciences University
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Intervention groupPanretinal Photocoagulation (PRP)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.
Primary Outcome Measures
NameTimeMethod
Life Qualityup 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

RNFLup to 30 days

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

Retinal thickness in the central part of Foveaup to 30 days

Measured by SD-OCT

Choroid thickness in the central part of Foveaup to 30 days

Measured by EDI-OCT

BCVAup to 3 months

best corrected visual acuity which measured by SD-OCT

Contrast sensitivityup to 3 months

Contrast sensitivity which measured by Melbourne edge test

Angiography with fluoresceinup to 3 months

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

Physical examination of PDRup to 3 months

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mohammad Sadegh Bagheri Baghdasht

🇮🇷

Tehran, Iran, Islamic Republic of

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