To compare the safety and efficacy of Topical Cyclosporin a (0.05%) with Topical Tacrolimus (0.03%), In patients of moderate to severe dry Eye

Study Design: Institution based, Proscpective, Interventional, double blinded, Randomised, parallel group, active controlled

Study Setting: OPD and Cornea Clinic at Regional Institute of Ophthalmology (RIO), Kolkata.

Period of Study: 6 months (January, 2022 – August, 2022).

Study Population: Patients of Dry Eye presenting at OPD and Cornea clinic of RIO, Kolkata.

Sample Size: 150 patients (75 in each group)

[Sample size is evaluated on the basis of prevalence of Dry Eye patients in Cornea Clinic and OPD in RIO.]

Inclusion Criteria:

1.Patients with Dry eye symptoms such as Discomfort, Fatigue and Gritty sensation

2.Schirmer’s Test <10mm in 5 minutes

3.tBUT <10 sec

4.Presence of Punctate staining in the Fluorescence NEI score > 3

5. OSDI score > 15

Exclusion Criteria:

1.Previous Eye Surgery

2.Use of ocular medication other than tear substitutes.

3.Contact lens wearer

4.Glaucoma patients

5.Pregnant or Lactating Mothers

6.Presence of any microbial infection.

Study Technique and data collection:

1.History taking.

2.Discomfort scoring by OSDI Questionnaire as a screening survey for Dry Eye.

3.Clinical examination.

4.Ocular Surface evaluation done by Fluorescent staining for corneal damage.

5.Relevant investigation.

6.Tear evaluation by Schirmer’s test under topical anesthesia Paracain drop with standard tear strip kept in conjunctival sac for 5 min.

7.Tear evaluation will be done by tBUT test.

8.Proper Slit Lamp examination to evaluate ocular adnexa and ocular surface.

Study Tools:

1.OSDI Questionnaire

2.Slit Lamp

3.Fluorescent Strip

4.Schirmer Strip

Investigations:

1.Schirmer’s test

2.tBUT test

3.Slit Lamp Examination

STATISTICAL ANALYSIS PLAN

All statistical analysis will be done using IBM SPSS (Statistical Package for the Social Sciences)

SELECTION OF CASES

Subjects presenting with Moderate to Severe Dry Eye at the RIO OPD and cornea clinic, Medical College and Hospital Kolkata and satisfying all the inclusion and exclusion criteria wee selected as cases. These pools of patients are divided into two groups randomly and they were given Topical Cyclosporin A (0.05%) and Topical Tacrolimus (0.03%) and followed up for a period of 6 months.

DATA COLLECTION

Data collection will be done with the help of a OSDI questionnaire containing detailed history and examination. Examination will be carried out with the help of Schirmer’s test, tBUT test, Slit Lamp Examination.

PARAMETERS AND PROCEDURES

1.History taking.

2.Discomfort scoring by OSDI Questionnaire as a screening survey for Dry Eye.

3.Clinical examination.

4.Ocular Surface evaluation done by Fluorescent staining for corneal damage.

5.Relevant investigation.

6.Tear evaluation by Schirmer’s test under topical anesthesia Paracain drop with standard tear strip kept in conjunctival sac for 5 min.

7.Tear evaluation will be done by tBUT test.

8.Proper Slit Lamp examination to evaluate ocular adnexa and ocular surface.

FOLLOW UP

0 visit, 1st week, 1st month, 3rd month,

In all subsequent visits tear evaluation done by Schirmer’s test and tBUT test, Ocular Surface evaluation done by Fluorescent staining for corneal damage, slit lamp examination to evaluate ocular adnexa and ocular surface.