Safety and efficacy of rho-kinase inhibitor for treatment of postoperative striate keratopathy.

Aim: To study the safety and efficacy of rho-kinase inhibitor in the treatment of post operative striate keratopathy

Objectives:

1.To help improve compliance with monotherapy

2.To aid in faster recovery of the patient

INTRODUCTION:

Striate keratopathy and raised intraocular pressure are common complications of cataract surgery. Endothelial cells maintain the relative state of dehydration in cornea and thus maintain the transparency. Any damage to endothelial cells intraoperatively may present as corneal edema. This damage may have a multifactorial causation like instrumentation, toxic solutions or ultrasonic energy used for phacoemulsification.

Hypertonic saline in combination with oral steroids and drugs to lower the intraocular pressure are the current main stay for treatment of striate keratopathy.

This treatment is only symptomatic and does not have any effect on endothelial cell function. Ripasudil is a Rho-kinase inhibitor which have been formulated as eye drops that have been approved for clinical use. Ripasudil since 2014 has been available in Japan for the treatment of glaucoma. Rho-kinase inhibitors have been found effective in the treatment of glaucoma and endothelial cells disorders. They help improve endothelial cell functionality and not just symptomatic treatment.

The effectiveness of rho-kinase inhibitors for corneal endothelium protection has been established in fields such as regenerative medicine, in which human corneal endothelial cell injection with a rho-kinase inhibitor was able to treat bullous keratopathy (BK) without conventional keratoplasty.  Limiting the treatment to one drug which would effectively have endothelial cell protection action and intraocular pressure lowering effect would increase patient compliance and give better outcomes.

Ripasudil(0.4%) is currently approved for use in Japan and Korea while Netarsudil is approved for use in USA and Canada . Ripasudil studies have been proven to shown effective along with less to no side effects**.**

Therefore the rho-kinase chosen for this study is ripasudil.

This study will   give an improved understanding of the safety and efficacy of rho-kinase inhibitors in comparison to current conventional treatment. It will help to quantify the occurrence of secondary glaucoma and the patients requiring DSEK post the use and disallowance of rho-kinase inhibitors in case and control subjects respectively

**STUDY DESIGN-**A CASE CONTROL STUDY

SOURCE OF DATA:

POST OPERATIVE CASES OF STRIATE KERATOPATHY IN IPD OF DEPARTMENT OF OPHTHALMOLOGY AT B.L.D.E. (DEEMED TO BE UNIVERSITY)’s S.H.R.I. B.M. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA.

DURATION OF STUDY: 2 years

METHOD OF COLLECTION OF DATA:

A case control study would be carried out on patients with post operative striate keratopathy attending the in-patient department of ophthalmology, B.L.D.E.’s Shri B.M. Patil Medical College, Hospital and Research Centre. As a standard protocol, all post operative cataract patients would be investigated for striate keratopathy. A clinical diagnosis of striate keratopathy is established by the presence of corneal edema with Descemet’s folds after cataract surgery in an eye with a relatively healthy and clear cornea and in the absence of obvious Descemet’s membrane detachment. They would be screened by complete ophthalmic examination, including

         Detailed history

         Best-corrected visual acuity

         Slit lamp examination

         Iop measurement

Grading for post MSICS corneal edema [13]

GRADE 0- clear cornea

GRADE 1 – hazy cornea

GARDE 2- foggy cornea/ DM folds/ striae, poor****IOL reflex

GARDE 3 – cloudy cornea / DM folds/ striae, poor IOL reflex  , loss of iris details

GRADE 4 opacified cornea, DM folds/ striae, poor IOL reflex  , loss of pupillary  details

We would perform specular microscopy on day 1 and day 5  to compare the corneal endothelium before and post the use of ripasudil in post operative striate keratopathy with respect to following parameters

         Endothelial cell density

         Central corneal thickness

         Highest corneal thickness

Inclusion Criteria-

a) Striate keratopathy post uneventful cataract surgery [Both SICS & Phacoemulsification ]

b) Pre operative healthy clear cornea

c) No DMD

Exclusion Criteria-

a) Pre existing corneal disorder

b) DMD

c) Aphakia, Vitreous in AC

d) Endophthalmitis

e) Known case of glaucoma

OUTCOMES EVALUATED

PRIMARY OUTCOME

1. Decrease in CCT

2.Improvement of corneal clarity

3.Improvement of endothelial cell density

4.Duration of Visual improvement

SECONADARY OUTCOME

1.IOP control

2.Progression to PBK

3.To monitor adverse drug reactions

Patients with post operative striate keratopathy will be divided in two groups by simple random sampling

GROUP 1

Patients prescribed

·         Eye drops Ripasudil 0.4% BD

GROUP 2

Patients prescribed

•          Sodium chloride 5% QID

•          Sodium chloride 6% HS

Brimonidine 0.15% and Timolol 0.5%