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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04436900
Enrollment
20
Registered
2020-06-18
Start date
2018-04-10
Completion date
2019-04-10
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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

Interventions

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.

Sponsors

Baqiyatallah Medical Sciences University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Life Qualityup to 3 monthsA 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 daysretinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)
BCVAup to 3 monthsbest corrected visual acuity which measured by SD-OCT
Retinal thickness in the central part of Foveaup to 30 daysMeasured by SD-OCT
Choroid thickness in the central part of Foveaup to 30 daysMeasured by EDI-OCT
Physical examination of PDRup to 3 monthsAn eye exam performed by an ophthalmologist will determine if there is retinopathy
Contrast sensitivityup to 3 monthsContrast sensitivity which measured by Melbourne edge test
Angiography with fluoresceinup to 3 monthsBy injecting fluorescein into the vein and then taking an X-ray to diagnose PDR

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026