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Congenital Cloudy Cornea:New Therapy Using Topical Eye Drops

Corneal Dystrophies Caused by SLC4A11 Mutation: A Promising New Paradigm Shift in Therapy Using an Ophthalmic Nonsteroidal Anti-Inflammatory Eye Drops

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034382
Enrollment
30
Registered
2021-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: Nepafenac 0.1% Ophthalmic Suspension: Nepafenac 0.1% eye drops Dosage- 1 drop QID for 6 months Control Intervention1: Carboxy-methylcellulose sodium lubricant eye drops 0.5%w/v: Carboxy

Sponsors

Hyderabad Eye Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1.Clinical change in the corneal transparency in the patients with CHED (slitlamp) 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

MeasureTime frame
1. Change in visual acuity in patients of CHED (Subjective Refraction) 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

Countries

India

Contacts

Public ContactNeet Mehta

L V Prasad Eye Institute

mehta.neet28@gmail.com9712002747

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026