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To Compare the Outcomes of Accelerated Transepithelial Corneal Cross Linking using HPMC riboflavin versus riboflavin containing Vitamin E Tocopheryl Polyethylene Glycol Succinate(TPGS) in patients with progressive Keratoconus( comparison between two dyes used in corneal cross linking in keratoconus)

To Compare the Outcomes of Accelerated Transepithelial Corneal Cross Linking using HPMC riboflavin versus riboflavin containing Vitamin E Tocopheryl Polyethylene Glycol Succinate(TPGS) in patients with progressive Keratoconus - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084324
Enrollment
50
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: H186- Keratoconus

Interventions

Intervention1: Riboflavin containing Vitamin E Tocopheryl Polyethylene Glycol Succinate(TPGS): These patients will undergo accelerated Transepithelial corneal cross linking using 9mW/cm2 of continuous

Sponsors

Poppy Debbarma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18 years or above 2. Thinnest pachymetry of 360 micrometer or above on Pentacam 3. K-max of 65D or less onScheimpflug imaging with Pentacam 4. Grade 1-3 keratoconus by Belin ABCD classification on Pentacam. 5. Corrected distance visual acuity (CDVA) of less than 20/20 on the Snellen vision chart 6. Endothelial cell density of 2000 cells/mm2 or above 7. Absence of any ocular surface disorders and other active ocular allergic conditions

Exclusion criteria

Exclusion criteria: 1. Presence of advanced keratoconus associated with subepithelial scarring 2. History of herpetic keratitis or recurrent corneal erosions 3. Previous corneal surgery 4. Previous history of cross linking 5. Presence of any corneal guttae or other endothelial pathology. 6. Patients who are pregnant or breast feeding. 7. Patients with autoimmune diseases.

Design outcomes

Primary

MeasureTime frame
Demarcation line depth and visibility to be measured on Swept source OCT at 8 weeks after the CXL procedure procedureTimepoint: 8 weeks after the CXL procedure

Secondary

MeasureTime frame
1. Change in total corneal densitometry at 3 months & 6 months post CXL compared to pre CXL values Timepoint: 3 months & 6 months;2. Change in maximum keratometry(Kmax) 3 months & 6 months after CXL compared to pre CXL values Timepoint: 3 months & 6 months;3. Change in total corneal Higher order aberrations at 3 months & 6 monthsTimepoint: 3 months & 6 months

Countries

India

Contacts

Public ContactPoppy Debbarma

Post Graduate Institute of Medical Education and Research

drchintansingh@yahoo.co.in8872016281

Outcome results

None listed

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