Overview

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 (

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dr Cipto Mangunkusumo General Hospital
Treatments:
alpha-Tocopherol
Hyaluronic Acid
Ophthalmic Solutions
Retinol palmitate
Tocopherols
Tocotrienols
Vitamin A
Vitamin E
Vitamins
Criteria
Inclusion Criteria:

- DM patients with NPDR or PDR

- Corneal sensitivity less than 45 mm with Cochet Bonnet esthesiometer

Exclusion Criteria:

- Patient with anterior chamber inflammation

- Patient with history of ocular surgery (ex. Repair of corneal rupture, cataract
surgery, Lasik)

- Patient with history of cerebrovascular event that may affect cognitive function

- Patient had event of disease which may impact corneal sensitivity (ex. Viral
keratitis, ophthalmic Herpes Zoster)

- Patient with corneal cicatrix

- Patient on anti-allergic medication

- Pregnant or lactating woman