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临床试验/CTRI/2024/03/064395
CTRI/2024/03/064395尚未招募Unknown

Transepithelial photorefractive keratectomy : A randomized comparative study between two-step and one-step techniques of transepithelial PRK and the rate of wound healing with different lubricating eye drops.

Ganthi Chetana Lakshmi1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
visual acuity

研究概览

简要总结

To find if there is any difference in the 1 month post -op visual outcome between the eyes which have undergone two step t-PRK vs single step t-PRK.

Rate of corneal epithelial wound( created by the t-PRK) healing using 3 different lubricating eye drops with varying composition

  1. PLAIN SODIUM HYALURONATE 0.1%

  2. POLYETHYLENE GLYCOL 0.4% w/v, PROPYLENE GLYCOL 0.3% w/v, SODIUM PERBORATE 0.028% w/v, HYDROXYPROPYL GUAR GUM

  3. SODIUM HYALURONATE 0.15% w/v, POLYETHYLENE GLYCOL 0.3% w/v, PROPYLENE GLYCOL 0.3% w/v, HYDROXYPROPYL GUAR

Area will be calculated using an app called SketchAndCalc.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • People who have myopic astigmatism with a spherical error between -1 to -6 diopters and a cylindrical error between -0.5 to -4 diopters.
  • People who have a stable refractive error at least for the past 1 year.
  • People who can come for a followup duration of at least 1 month.
  • Normal corneal tomography.
  • Minimum pachymetry of 470 micrometers.

排除标准

  • History of any previous corneal surgery.
  • Family history of keratoconus.
  • History of keloid tendency.
  • Pregnant,lactating women( upto 6 months of delivery).
  • If the person has keratitis or corneal scar.
  • Any corneal dystrophies.
  • Hyperopia.

结局指标

主要结局

visual acuity

时间窗: visual acuity on 1 and 3 months | rate of corneal epithelial wound healing on days 1,3,5 and 1 month

rate of corneal epithelial wound healing

时间窗: visual acuity on 1 and 3 months | rate of corneal epithelial wound healing on days 1,3,5 and 1 month

次要结局

  • Pain & discomfort in eyes after surgery( t- PRK).

研究者

发起方
Ganthi Chetana Lakshmi
申办方类型
Other [Principal investigator]
责任方
Principal Investigator
主要研究者

Ganthi Chetana Lakshmi

Sankara eye hospital, Pedakakani, Guntur

研究点 (1)

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