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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Panretinal Photocoagulation (PRP)
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mohammad Sadegh Bagheri Baghdasht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

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
RNFL
retinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)
BCVA
best corrected visual acuity which measured by SD-OCT
Retinal thickness in the central part of Fovea
Measured by SD-OCT
Choroid thickness in the central part of Fovea
Measured by EDI-OCT
Physical examination of PDR
An eye exam performed by an ophthalmologist will determine if there is retinopathy
Contrast sensitivity
Contrast sensitivity which measured by Melbourne edge test
Angiography with fluorescein
By injecting fluorescein into the vein and then taking an X-ray to diagnose PDR

Secondary Outcome Measures

Full Information

First Posted
June 12, 2020
Last Updated
June 16, 2020
Sponsor
Baqiyatallah Medical Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT04436900
Brief Title
Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy
Official Title
Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
February 10, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baqiyatallah Medical Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Panretinal Photocoagulation (PRP)
Intervention Description
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 Measure Information:
Title
Life Quality
Description
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
Time Frame
up to 3 months
Title
RNFL
Description
retinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)
Time Frame
up to 30 days
Title
BCVA
Description
best corrected visual acuity which measured by SD-OCT
Time Frame
up to 3 months
Title
Retinal thickness in the central part of Fovea
Description
Measured by SD-OCT
Time Frame
up to 30 days
Title
Choroid thickness in the central part of Fovea
Description
Measured by EDI-OCT
Time Frame
up to 30 days
Title
Physical examination of PDR
Description
An eye exam performed by an ophthalmologist will determine if there is retinopathy
Time Frame
up to 3 months
Title
Contrast sensitivity
Description
Contrast sensitivity which measured by Melbourne edge test
Time Frame
up to 3 months
Title
Angiography with fluorescein
Description
By injecting fluorescein into the vein and then taking an X-ray to diagnose PDR
Time Frame
up to 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mohammad Sadegh Bagheri Baghdasht
City
Tehran
ZIP/Postal Code
0
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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