跳至主要内容
临床试验/CTRI/2018/03/012741
CTRI/2018/03/012741Other1 期

Scheimpflug Imaging assisted measurement of pre-corneal tear film thickness and its changes after LASIK.

Giridhar Eye Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年12月15日最近更新:

试验速览

阶段
1 期
状态
Other
入组人数
20
试验地点
1
主要终点
Detect candidates who can potentially develop chronic tear film disfunction after LASIK with a scheimpflug camera based imaging system.

研究概览

简要总结

The pre-corneal tear film is an important component of the anatomy and physiology of the eye and performs several functions. It prevents the epithelial cells from dessication, facilitates eyelid movement by lubrication, provides a smooth refracting surface on the cornea, supplies nutrients and oxygen necessary for corneal metabolism, contributes to the ocular antimicrobial defense mechanism, removes metabolic waste products, eliminates foreign bodies from the ocular surface and protects the cornea and conjunctiva from atmospheric and chemical irritants.

The Wavelight Oculyzer is an instrument that uses a rotating camera to image the shape and thickness of the cornea using the Scheimpflug principles. Fluorescein is a dye that is commonly used to study the tear film. By adding fluorescein to the tear film the Wavelight Oculyzer can be used to non-invasively measure the thickness of the tear film.

LASIK (Laser In-Situ Keratomileusis) is one of the most commonly performed cornea refractive surgeries to provide spectacle free vision. It involves creation of a partial thickness flap of the cornea, reflection of the flap, application of excimer laser (wavelength 193 nm) to ab late corneal tissue followed by replacement of the flap.

Aims and Objectives:

(a) To devise a novel method for measuring the pre-corneal tear film thickness.

(b) To study the changes in pre-corneal tear film thickness that occur after LASIK.

(c) To examine the utility of a Scheimpflug Camera based imaging system as a non-invasive objective tool to detect candidates who can potentially develop chronic tear film dysfunction after LASIK.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • All patients willing to undergo LASIK treatment.

排除标准

  • (a) Patients with corneal erosions, keratitis, corneal ectasia, corneal scars and abnormality of lacrimal drinage apparatus will be excluded from the study (b) Patients who are unable to maintain sustained fixation on a near target will be excluded from the study (c) patients with contraindications for LASIK will be excluded from further evaluation (d) patients under the age of 18 will be excluded.

结局指标

主要结局

Detect candidates who can potentially develop chronic tear film disfunction after LASIK with a scheimpflug camera based imaging system.

时间窗: 18 Months

次要结局

  • Tear film thickness at the corneal apex will be evaluated and the pattern of each tear film pachymetry map will be determined.(18 Months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验

LASIK SURGERY | 临床试验