跳至主要内容
临床试验/NCT04383301
NCT04383301已完成不适用

Combined Corneal Wavefront-guided Transepithelial Photorefractive Keratectomy and Accelerated Corneal Collagen Cross-linking Following Intra Corneal Ring Segment Implantation in Management of Moderate Keratoconus

Shaaban Elwan2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Refractive changes

研究概览

简要总结

Background: Keratoconus leads to gradual progressive loss of vision in young and adult patients. For visual rehabilitation and to hinder keratoconus progressionthe investigators designed this study to help the keratoconus patients to improve and stabilize their vision.

Design: This is a prospective consecutive uncontrolled study.

Patients and Methods:

This study includes 36 eyes of 36 patients with moderate degree o keratoconus (KC) undergoing combined wave front guided transepithelial photorefractive keratectomy (TPRK) and accelerated corneal collagen crosslinking (ACXL) after intracorneal ring segment (ICRS) implantation. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs) will be evaluated at baseline, after ICRS implantation, and at1, 3, 6, and 12 months after combined TPRK and CXL.

详细描述

Patients and Methods:

This study conducted upon 36 eyes of 36 patients with moderate keratoconus who undergoing combined corneal wavefront-guided TPRK and accelerated corneal CXL at least 3 months after ICRS implantation in the period between October, 2018 and April 2020, at the Security Forces Hospital, Ophthalmology Department, Riyadh, Kingdom of Saudi Arabia. The study was approved by SFHP ethical board committee (IRB registraion number: 18-289-54) and was adhered to the tenets of the Declaration of Helsinki as well as followed good clinical practices. All patients provided informed written consent for the study and for publication. All included patients undergoing combined corneal wavefront guided TPRK and corneal ACXL at least 3 months after ICRS implantation. Grading of keratoconus was based on the Amsler Krumeich classification. Progression was defined as one or more of the following changes over a period of 6 months: an increase of ≥1.00 diopter (D) in maximal keratometry values, an increase of ≥1.00 D in manifest cylinder, and an increase of ≥ 0.50 D in MRSE.

Examinations and measurements:- At baseline, the preoperative examination included UDVA, CDVA, manifest and cycloplegic refraction, slit lamp biomicroscopy, tonometry, Pentacam camera, tomography, and dilated fundus examination using binocular ophthalmoscopy. If patient use contact lenses it should be stopped 3 weeks before exam date, and medical history, including any systemic diseases, were recorded. After ICRS implantation (before combined TPRK and ACXL), and at 1, 3, 6, and 12 months after combined TPRK and CXL, all patients undergoing complete ophthalmic examinations, which included examinations for UDVA and CDVA with a Snellen chart, manifest refraction (MR). The corneal indices measured at the 8-mm zone using the Scheimpflug tomography system with Pentacam camera (OCULUS- Netzteil Art., Pentacam HR, Germany), and for measuring changes in corneal aberrations, including HOAs, coma, and spherical aberrations, corneal wavefront analysis implemented using corneal topographic data with tomography (Sirius, SCHWIND eye-tech-solutions GmbH, Kleinostheim, Germany). Root mean square (RMS) values of the corneal HOAs, with analysis up to the 7th order by expanding the set of Zernike polynomials, were calculated. Any postoperative complications, corneal haze , wound healing time were estimated. Patients overall satisfaction for the procedure were asked at last follow up and all data were recorded.

Surgical technique:-

First step procedure:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 48 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient with age > 20 years old and intolerant to contact lense use
  • patients had moderate keratoconus (45-54 D in both meridians) without corneal scarring
  • Central pachymetry ≥ 400 μm and if progression had been noted over the previous 6 months.

排除标准

  • Patients with central or paracentral corneal scarring
  • Central pachymetry <400 μm, systemic autoimmune disease
  • History of herpetic keratitis, pregnancy, lactation, or severe dry eye syndrome.

结局指标

主要结局

Refractive changes

时间窗: one year

Refractive changes in the mean sphere, mean cylinder and manifest refractive spherical equivalent (MRSE)

UDVA

时间窗: one year

Uncorrected distance visual acuity

Corneal Indices

时间窗: 0ne year

All corneal indices including steep, flat, mean and maximal keratometries

CDVA

时间窗: one year

corrected distance visual acuity

次要结局

  • HOA and coma aberrations(1 year)

研究者

发起方
Shaaban Elwan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shaaban Elwan

Assistant professor of ophthalmology

Minia University

研究点 (2)

Loading locations...

相似试验