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

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Procedure: Panretinal Photocoagulation (PRP)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |