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临床试验/CTRI/2025/01/079133
CTRI/2025/01/079133尚未招募4 期

Visual and Topographic Outcomes of Corneal Allogenic Ring Segments in Keratoconus

Dr Shivohn Annalie da Silva1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
87
试验地点
1
主要终点
Improvement in UCVA by range of ≥ 2 lines

研究概览

简要总结

My Postgraduate Thesis is on Visual and Topographic Outcomes of corneal allogenic intrastromal ring segments in Keratoconus.

Keratoconus is a slowly progressive, non inflammatory ectatic corneal disease characterized by changes in corneal collagen structure and organization. Prevalence of keratoconus (KC) is estimated at 2300/100,000 in Central India (0.0003–2.3%) highlighting the fact that keratoconus is much more prevalent than what is assumed.

Corneal collagen cross‐linking is effective in stabilizing the progression of the disease but does not have a major impact on the improvement of visual acuity. Common methods of vision correction for keratoconus range from spectacles and rigid gas‐permeable contact lenses to other specialized lenses such as piggyback, Rose‐K, or Boston scleral lenses.

Intrastromal corneal ring segments (ICRS) are small curvilinear segments which are made of PMMA, synthetic material that are placed deep in the corneal stroma to alter the corneal curvature and regularization of the corneal surface. However, being made of synthetic material, upto 30% rate of complications ranging from innocuous to sight threatening are reported.

Corneal Allogenic Intrastromal Ring Segments is a new technique that utilizes a principle similar to synthetic segments but with the use of allogenic segments created from donor corneal buttons. This technique aims at decreasing the complications associated with the use of synthetic material within the patient’s corneal stroma and improving the visual outcomes.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Grade 1 to 4 Keratoconus patients (Amsler Krumeich grading) showing progression with sufficient minimum pachymetry.

排除标准

  • Autoimmune and immunodeficiency syndromes Previous viral keratitis Thin cornea less than 350 micrometers.

结局指标

主要结局

Improvement in UCVA by range of ≥ 2 lines

时间窗: Follow up at 1 week, 1 month, 3 months, 6 months and 1 year.

Improvement in BCVA by ≥ 1 line

时间窗: Follow up at 1 week, 1 month, 3 months, 6 months and 1 year.

Decrease in spherical and astigmatic error

时间窗: Follow up at 1 week, 1 month, 3 months, 6 months and 1 year.

Decrease in keratometry

时间窗: Follow up at 1 week, 1 month, 3 months, 6 months and 1 year.

次要结局

  • Incidence of inflammatory keratitis(Over correction or Under Correction of Refractive error)

研究者

发起方
Dr Shivohn Annalie da Silva
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shivohn Annalie da Silva

Sankara Eye Hospital, Coimbatore

研究点 (1)

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