CTRI/2019/06/019697Other未知
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:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 ââ?°Â¥ 48 D
- •5. Patients ââ?°Â¥ 18 years of age
- •6. Patients with clear cornea
- •7. Patients with corneal thickness ââ?°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.
排除标准
- •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.
研究者
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