Congenital Cloudy Cornea:New Therapy Using Topical Eye Drops
Phase 2
- Conditions
- Health Condition 1: H00-H59- Diseases of the eye and adnexa
- Registration Number
- CTRI/2021/06/034382
- Lead Sponsor
- Hyderabad Eye Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children upto 9 years of age diagnosed with CHED (Congenital Hereditary Endothelial Dystrophy) with bilaterally equal corneal involvement
-Patients agreeing on a regular monthly follow-up for a minimum of 6 months
Exclusion Criteria
1. Patients undergone eye surgery (PK,DSEK,DMEK, Glaucoma surgery, etc)
2. Patient with eye pathologies like-glaucoma,dry eye,nystagmus,cataract,corneal ulcer,reduced corneal sensations,etc
3. Not able to come for follow up
4.Asymmetrical corneal involvement
5.Allergy to the drug
6. Patients with asthma or bleeding dyscrasias
7. Non-cooperative children
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Clinical change in the corneal transparency in the patients with CHED (slitlamp) <br/ ><br>2.Change in the corneal transparency on Densitometry in the patients with CHED (Oculyzer machine)Timepoint: Measured at each monthly follow-up till study completion
- Secondary Outcome Measures
Name Time Method 1. Change in visual acuity in patients of CHED (Subjective Refraction) <br/ ><br>2. Change in the Corneal thickness Pachymetry/ Anterior Segment OCT (Optical Coherence Tomography) readings at each visitTimepoint: Measured at each monthly follow-up till study completion