跳至主要内容
临床试验/CTRI/2023/07/055136
CTRI/2023/07/055136尚未招募不适用

To study the Outcomes of Intrastromal keratoplasty withBiosynthetic corneas Versus Biolenticules from donor corneas in cases of Keratoconus

Rajendra Prasad Centre for Ophthalmic Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
tectonic support to cornea, change in astigmatism

研究概览

简要总结

Written informed consent will be taken from the patient. A detailed history and clinical examination will be done according to the above-mentioned parameters which will include visual acuity testing of both uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) measured using Snellen’s Chart. A detailed slit lamp examination will be done by an expert cornea specialist, a dilated fundoscopy to rule out any coexistent ocular disorders, non-contact Tonometry for Intra Ocular Pressure measurement and Central Corneal Thickness will also be done. High-Definition Anterior segment OCT, optical biomechanics and corneal wavefront aberrometry will be performed. A single surgeon, Prof. Namrata Sharma, will be performing all the surgeries under topical anesthesia. Under topical anesthesia, a corneal intrastromal pocket will be created using Femtosecond LASER system which will be extended by 0.75 to 1.0mm more than the base of cone of keratoconus cornea. Under microscope visualization intrastromal pocket will be opened using blunt lamellar dissection. Next, the biosynthetic cornea will be trephined using handheld trephine to 0.5mm oversize the base of the cone and will be placed in the intrastromal pocket. Entry wound will then be sealed with the help of fibrin glue. The patient will be evaluated at day 1, 1 week, 1 month and 3 months for visual acuity (uncorrected distance visual acuity, corrected distance visual acuity), Intraocular pressure by Non-contact Tonometry, Slit lamp bio microscopic examination, Fundus examination, High-Definition Anterior Segment Optical Coherence Tomography, corneal biomechanics and Tomography.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of Keratoconus Age more than 18 years Contact lens intolerant Thinnest Pachymetry > 250 microns Patients giving informed consent for surgery and willing for follow up.

排除标准

  • Healed hydrops Diabetes, connective tissue disease or atopy Pregnant or lactating patients Patient not willing to give consent.

结局指标

主要结局

tectonic support to cornea, change in astigmatism

时间窗: changes seen at Post operative day 1, day 7, at 4 weeks and 3month

次要结局

  • change in lower order aberrations and higher order aberrations of cornea(changes seen at Post operative day 1, day 7, at 4 weeks and 3month)

研究者

发起方
Rajendra Prasad Centre for Ophthalmic Sciences
申办方类型
Government medical college

研究点 (1)

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