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

NCT ID: NCT04436900

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-10

Study Completion Date

2019-04-10

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

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Panretinal Photocoagulation (PRP)

Intervention Type 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.

Interventions

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Panretinal Photocoagulation (PRP)

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 Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baqiyatallah Medical Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Sadegh Bagheri Baghdasht

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohammad Sadegh Bagheri Baghdasht

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.BMSU.REC.1396.455

Identifier Type: -

Identifier Source: org_study_id

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