Study of the factors affecting dry eye following phacoemulsification
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
-
aim and objectives: To determine association of post phacoemulsification dry eye with various risk factors such as :
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Baseline factors: age, gender, chronic illness, and medication they would be currently on.
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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.
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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.
- 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 ï¬lter 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.
- TBUT:(to test tear film stability and Meibomian gland disorder) Fluorescein TBUT is one of the measures of tear ï¬lm 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 ï¬lm is examined using a broad beam of the slit lamp with a blue ï¬lter. The time lapse between the last blink and the appearance of the ï¬rst randomly distributed dark discontinuity in the fluorescein stained tear ï¬lm is the TBUT. Breakup times less than 10 s are considered abnormal.
- 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.
- 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
Dr Neetha KIR
Kasturba medical college ,Manipal
