The efficacy of intense pulsed light therapy to treat post refractive surgery dry eye
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Tear film analysis by MS39, mebonian gland view and partial blink rate by lipiview, and refractive status of eye by HD analyser.
研究概览
简要总结
AIM
Through this study we aim to identify the Efficacy of Intense Pulsed Light Therapy to Treat Post Refractive Surgery Dry Eyes.
OBJECTIVES
To study safety of IPL in post-operative dry eye.
Incidence of dry eye in post refractive surgery even after IPL therapy.
Quality of vision in post refractive surgery dry eye patient treated with IPL.
Difference between pre and post surgery IPL efficiency (d/t change in corneal anatomy).
To evaluate patient comfort during the procedure.
PROCEDURE of VISITS :
Patients come with the symptom of dry eye are sent for the tests for evaluation.
After the tests results a diagnosis of DRY EYE is made.
Patient undergoes 1st session of IPL.
Patient undergoes 2nd session of IPL after 15 days of 1ST session.
Patient can undergo REFRACTIVE SURGERY from 3rd day to 1 month after 2nd session of IPL.
Patient has to undergo 3rd session of IPL after 1 month of the 2nd session of IPL.
Patient has to undergo 4th session of IPL after 1 month of the 3rd session of IPL.
Patient visits for 1stfollow-up visit after 1 month of 4th session of IPL.
Patient visits for 2ndfollow-up visit after 2 month of 1st follow-up visit.
Patient visits for 3rdfollow-up visit after 3 month of 2nd follow-up visit.
PROCEDURE OF IPL:
The machine used for IPL therapy is **LUMENIS M22.**Eyes of the patient are covered, cupping gel is applied on face from tragus to tragus.
The hand-piece of IPL has an optical filter either 560 or 590, based on the skin type of patient.
A light guide is also placed in the slot provided in the hand piece and the light is delivered in coupling gelly from tragus to tragus in 2 passes.
After the delivery of first light the observation is made for skin changes so as to assess the damage caused if any. If any damage is observed the optical filter is decreased.
The subsequent light is delivered adjacent to the previous one taking care that the two points don’t overlap.
Patient is advised to not get exposed to sunlight for 48hrs if it is unavoidable use a liberal amount of suns screen on the treated area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with refractive surgery.
- •Patients over 18 years of age.
- •Patient having clinical or sub clinical dry eye.
- •Patient willing to undergo a refractive surgery procedure.
- •Patients having adequate corneal thickness to undergo refractive surgery.
- •Patients with stable refraction for more than 1 year.
- •Patients giving consent to be part of study.
- •Patients who are willing to attend all the follow ups.
- •Skin type I-V according to Fitz Patrick.
排除标准
- •Patients without any refractive error and undergoing IPL.
- •Patients under 18 year of age.
- •Patients without dry eye.
- •Patient not willing to undergo refractive surgery.
- •Patient opting for other modality to treat dry eye.
- •Patient with unstable refraction in past 1 year.
- •Patients who fail to attend all follow ups.
- •Patient who is uncooperative.
- •Patient with active ocular infection.
结局指标
主要结局
Tear film analysis by MS39, mebonian gland view and partial blink rate by lipiview, and refractive status of eye by HD analyser.
时间窗: Improvemnet in tear film status by MS39 Machine will be checked 1 month, 2 month and 3 months post last IPL session
次要结局
- Improvement in Dry Eyes post refractive surgery(2 more IPL sessions will be done post refractive surgery and Improvemnet will be checked 1 month, 2 month and 3 months post last IPL session)
研究者
Dr Annirudh Gupta
Nethradhama Super Speciality Eye Hospital