跳至主要内容
临床试验/CTRI/2024/04/065802
CTRI/2024/04/065802已完成不适用

Study of the factors affecting dry eye following phacoemulsification

Dept of OphthalmologyKasturba Hospital Kasturba Medical college Manipal1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Outcome measures include post-operative changes in OSDI scoring, ST-I, TBUT , LG staining and the correlation of the dry eye signs and symptoms with age, chronic disease presence, medications; site of the corneal incision; duration of exposure to microscopic light; C.D.E. value; type of lubricating eye drops used or not used.

研究概览

简要总结

  1. aim and objectives: To determine association of post phacoemulsification dry eye with various risk factors such as :

  2. Baseline factors: age, gender, chronic illness, and medication they would be currently on.

  3. Intraoperative factors: microscopic light exposure time, C.D.E., incision site of the main incision: temporal, supra temporal or infratemporal, type of anaesthesia used: sub tenon, peribulbar or topical.

  4. Post-operatively: the different types of lubricating drops such as sodium hyaluronate, carboxymethyl cellulose eye drops, hydroxy propyl methyl-cellulose eye drops, or no eye drops at all.

2 . Methodology

In this study the following tests will be used to assess the dry eye symptoms at pre-op visit; at 2 weeks  and 1 and half month follow up post surgery .3 month follow up would be done for patient who are compliant for the follow up.

  1. Schirmer’s test: type 1(ST-1)(to evaluate reflex and basal tear secretion}: The Schirmer test typically consists of a 35 * 5 mm strip of Whatman No. 41 filter paper that can be folded 5 mm from one end and is anchored to the patient’s lower eyelid. After 5 min, the amount of tear production is measured in millimeters; type 2:(to test basal tear secretion ) After Schirmer type 1, we instill anesthetic drops such as proparacaine eye drops and repeat the method of Schirmer’s type 1 measuring the amount of tear production in millimetres.
  2. TBUT:(to test tear film stability and Meibomian gland disorder) Fluorescein TBUT is one of the measures of tear film stability. It is performed by moistening a fluorescein strip with sterile non-preserved saline and applying it to the inferior tarsal conjunctiva. The precorneal tear film is examined using a broad beam of the slit lamp with a blue filter. The time lapse between the last blink and the appearance of the first randomly distributed dark discontinuity in the fluorescein stained tear film is the TBUT. Breakup times less than 10 s are considered abnormal.
  3. OSDI (Ocular Surface Disease Index)  questionnaire: This is used to assess the ocular symptoms associated with dry eye disease from symptoms to visual disturbances. The 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient’s life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to “none of the time” and 4 corresponding to “all of the time.” A final score calculated ranges from  0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.
  4. Lissamine green staining of cornea and conjunctiva:conjunctival staining using lissamine green was observed at least 1 minute but no more than 4 minutes after the instillation of dye through slit-lamp examination under dimmed white light.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Anyone fit for cataract surgery and is undergoing surgery at KH, manipal .who is willing and consented to be part of the study.

排除标准

  • Patients with lid disorders such as untreated meibomian gland disease; blepharitis;lag ophthalmos; bells palsy; and connective tissue disorders already been diagnosed with dry eye disease.
  • Any complication during the surgery or any modification to the surgery.
  • If the patient is on any topical medication including lubricants.
  • Any ocular condition such as uveitis, glaucoma or corneal diseases.
  • History of trauma to the eye.

结局指标

主要结局

Outcome measures include post-operative changes in OSDI scoring, ST-I, TBUT , LG staining and the correlation of the dry eye signs and symptoms with age, chronic disease presence, medications; site of the corneal incision; duration of exposure to microscopic light; C.D.E. value; type of lubricating eye drops used or not used.

时间窗: patient will be evaluated at pre-operative visit ,post surgery follow up at 2 weeks and at 6 weeks

次要结局

  • Outcome measures include post-operative changes in OSDI scoring, ST-I, TBUT , LG staining and the correlation of the dry eye signs and symptoms with age, chronic disease presence, medications; site of the corneal incision; duration of exposure to microscopic light; C.D.E. value; type of lubricating eye drops used or not used.(3 month post surgery if patient is willing for follow up)

研究者

发起方
Dept of OphthalmologyKasturba Hospital Kasturba Medical college Manipal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Neetha KIR

Kasturba medical college ,Manipal

研究点 (1)

Loading locations...

相似试验