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The Effect of Combination of Vitamin A, Vitamin E, Sodium Hyaluronate 0.15% Eye Drop Compared With Sodium Hyaluronate 0.1% Eye Drop to Tear Film Stability and Conjunctival Goblet Cells Density in Patient With Non-Proliferative Diabetic Retinopathy (NPDR), and Proliferative Diabetic Retinopathy (PDR)

NCT04000789 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-06-27

No results posted yet for this study

Summary

Commonly know that one of the complications caused by Diabetes Mellitus (DM) is microangiopathy. Microangiopathy in the long term may lead to neuropathy of the corneal nerves. Neuropathy of the cornea will lead to dry eyes in DM patient. One of the artificial tears used in treating dry eyes is sodium hyaluronate. But until recently no research had been done in examining the effect of giving combination of sodium hyaluronate, vitamin A and vitamin E in dry eyes. The antioxidant, and capability of vitamin A and E in promoting cell proliferation may alleviate the symptoms of dry eyes. In this paper we used Ocular Surface Disease Index (OSDI), Tear Break Up time, Schirmer I test and impression cytology to assess baseline and 28 days post therapy in patient with Non-Proliferative Diabetic Retinopathy (NPDR), and Proliferative Diabetic Retinopathy (PDR)

Conditions

Interventions

DRUG

Sodium Hyaluronate, Vitamin A, Vitamin E

Eye drops consisting of combination of Sodium Hyaluronate, Vitamin A, Vitamin E will be . given to patients in control groups

Sponsors & Collaborators

  • Dr Cipto Mangunkusumo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2019-12-31
Completion
2019-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04000789 on ClinicalTrials.gov