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A study to assess the outcome of two different corneal rings combined with corneal tissue strengthening treatment in patients with cone-shaped cornea

A Clinical Study to evaluate the Outcome after implantation of two different commercially available Intra Stromal Rings combined with Collagen cross linking in patients with Keratoconus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019697
Enrollment
54
Registered
2019-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: BIORING: 1.Material Medical Grade Poly Methyl Methacrylate CQ UV 2.Models BR5 (5mm optical zone) 3.Thickness BR5: 150�¼m to 350�¼m (in 50�¼m increments) 4.Arc BR5: 90�º, 120�º

Sponsors

Biotech Vision Care Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Unilateral/bilateral 2. A diagnosis of keratoconus, intolerance for contact lenses or glasses. 3. Progressing keratoconus. (Decrease in visual acuity of at least 1 line excluding non-corneal causes of deterioration/ steepening of at least 1D in steepest keratometry over last 6 months/ more than 1 in prescription of change of glasses or contact lens over the last 2 years) 4. Patients with Keratometric readings � 48 D 5. Patients � 18 years of age 6. Patients with clear cornea 7. Patients with corneal thickness � 450 microns at the proposed incision site. 8. Patient willing to participate and sign informed consent 9. Patient willing to come for all post-operative follow-up procedures as defined in study protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with maximum keratometry (K) values greater than 65.00 diopters (D), 2. Patients with keratometric readings 3. Apical opacity and scarring. 4. Hydrops. 5. Previous corneal or Intraocular surgery 6. Corneal thickness less than 450 microns at the planned site of Intrastromal rings implantation (5.0 mm optical zone). 7. Pregnancy & Lactation 8. Concurrent participation in another drug or device Study.

Design outcomes

Primary

MeasureTime frame
Uncorrected Visual acuity Best Corrected Visual acuityTimepoint: Pre-operative visit, 3, 6, and 12 Months Follow-up—

Secondary

MeasureTime frame
Refraction Change in Topography patterns Reduction in Spherical Equivalence refractive error Corneal Thickness Change in Keratometric values Endothelial cell count Adverse Event/complication after implanting BIO RING Timepoint: Pre-operative visit, 3, 6, and 12 Months Follow-up Adverse event: At Intra-Op, 1 Day, 7 Day, 1, 3, 6 and 12 Months Follow-up—

Countries

India

Contacts

Public ContactDr Mithun Thulasidas

Centre for sight

prateekteotia@gmail.com8750014567

Outcome results

None listed

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