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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04436900
• Other study ID #: IR.BMSU.REC.1396.455
• Status: Completed
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: June 2020
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 10, 2019
• Est. primary completion date: February 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Retinopathy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mohammad Sadegh Bagheri Baghdasht	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	RNFL	retinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)	up to 30 days
Primary	BCVA	best corrected visual acuity which measured by SD-OCT	up to 3 months
Primary	Retinal thickness in the central part of Fovea	Measured by SD-OCT	up to 30 days
Primary	Choroid thickness in the central part of Fovea	Measured by EDI-OCT	up to 30 days
Primary	Physical examination of PDR	An eye exam performed by an ophthalmologist will determine if there is retinopathy	up to 3 months
Primary	Contrast sensitivity	Contrast sensitivity which measured by Melbourne edge test	up to 3 months
Primary	Angiography with fluorescein	By injecting fluorescein into the vein and then taking an X-ray to diagnose PDR	up to 3 months