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

Biotech Vision Care Pvt Ltd0 个研究点目标入组 3 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•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 Ã¢â?°Â¥ 48 D
•5. Patients Ã¢â?°Â¥ 18 years of age
•6. Patients with clear cornea
•7. Patients with corneal thickness Ã¢â?°Â¥ 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.

•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.

发起方

Biotech Vision Care Pvt Ltd