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)

Not Applicable

• Conditions: Non-Proliferative Diabetic Retinopathy; Dry Eye Syndromes; Proliferative Diabetic Retinopathy New Vessels on Disc
• Interventions: Drug: Sodium Hyaluronate, Vitamin A, Vitamin E

• Registration Number: NCT04000789
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

Brief 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)

Detailed Description

The study is double blind randomized clinical trial, comparing the usage of combination of sodium hyaluronate 0.15%, vitamin A and vitamin E eye drops compared to sodium hyaluronate 0.1% eye drop only in patient with NPDR or PDR with decreased corneal sensitivity. The examination consisted of OSDI questionnaire, tear film break up time, Schirmer I, and goblet cell density, examined at baseline and 4 weeks (day 28) after the initial eye drops is given. For sample size calculation, estimated 96 patients are required to give statistical effect, this number already calculating the possibility of 20% drop out rate. Every eligible patient is then randomized with block randomization into each allocated arm. Statistical analysis used for this study is unpaired T test if the data distribution is normal, if not Mann-Whitney test will be used.

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Last Update Submitted: 2019-06-26
• Study First Posted: 2019-06-27
• Last Update Posted: 2019-06-27
• Study Start: 2019-07
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDR	Sodium Hyaluronate, Vitamin A, Vitamin E	-
NPDR	Sodium Hyaluronate, Vitamin A, Vitamin E	-
NPDR Comparator	Sodium Hyaluronate, Vitamin A, Vitamin E	-
PDR Comparator	Sodium Hyaluronate, Vitamin A, Vitamin E	-

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI) questionnaire	4 weeks	A questionnaire to measure subjective symptoms of dry eyes. Possible score of 0 (no dry eye) to 100 (severe dry eye). Measured at baseline, day 14 and day 28.
Tear Film Breakup Time	4 weeks	Measurement in seconds of tear film stability. The shorter the fluorescein tear break up time, the lower the tear film stability. Measured at baseline and day 28.
Schirmer I Test	4 weeks	Measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Measured at baseline and day 28.
Conjunctival Goblet Cell Density	4 weeks	Measurement of conjunctival goblet cell count per mm2. Measured at baseline and day 28.