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

Not Applicable

• Conditions: Health Condition 1: H186- Keratoconus

• Registration Number: CTRI/2019/06/019697
• Lead Sponsor: Biotech Vision Care Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 3

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

1. Patients with maximum keratometry (K) values greater than 65.00 diopters (D),

2. Patients with keratometric readings < 48 D

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ncorrected Visual acuity <br/ ><br>Best Corrected Visual acuityTimepoint: Pre-operative visit, 3, 6, and 12 Months Follow-up

Secondary Outcome Measures

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