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临床试验/NCT04343326
NCT04343326Unknown2 期

The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
30
试验地点
1
主要终点
Postoperative refractive error

研究概览

简要总结

It is aimed to investigate the role of supplemental systemic oxygen therapy during accelerated corneal collagen crosslinking (CXL).

In this prospective randomized clinical trial, patients with progressive keratoconus who are candidates for receiving CXL will be included. The patients will be randomized and allocated to three different CXL protocol. In the first group (OA-CXL), CXL is performed using an accelerated protocol (9 mW/ CM2 for 10 minutes) in addition to the delivery of systemic oxygen with a rate of 5 liters/min through a nasal mask for 10 minutes during UV-A ablation. Patients in the second group (A-CXL) will receive CXL with the same accelerated protocol without additional oxygen therapy. Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes is perfomed in the patients of the third goup (C-CXL). Maximum keratometry in Sirius corneal tomography as the primary outcome and uncorrected and corrected distance visual acuity (UDVA, CDVA) and corneal biomechanical properties including corneal resistance factor (CRF) and corneal hysteresis (CH) as secondary outcome measures are followed for a six- and 12-months period. A P-value of less than 0.05 is considered as statistically significance level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
— 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • definitive diagnosis of progressive keratoconus for whom CXL is indicated were enrolled in this study
  • The indication is identified by a cornea specialist and was considered as follows.
  • Patients with the definitive diagnosis of KC who aged 18 or more were considered for the procedure if they had an increase of 1 D in Kmax or an increase of 1D in the manifest cylinder over the past 12 months.

排除标准

  • patients with the previous history of corneal surgery
  • corneal scar or pathologies like herpetic eye disease or severe dry eye
  • corneal thickness less than 400 micrometers
  • pregnant or nursing women
  • corneal Kmax more than 60
  • age over 35 years
  • severe ocular surface disease

结局指标

主要结局

Postoperative refractive error

时间窗: 12 months

Sirius and ocular response analyzer

次要结局

  • Ocular biomechanics(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Rabbani Khah

Head of department

Shahid Beheshti University of Medical Sciences

研究点 (1)

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