Low-level Light Therapy Versus Intense Pulsed Light to Prevent Iatrogenic Dry Eye Disease After Cataract Surgery: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patient-reported symptoms of eye dryness (OSDI)
研究概览
简要总结
Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Cataract surgery, which is one of the most often performed interventions worldwide, can induce or worsen the symptoms of DED. Despite lack of guidelines on DED prophylaxis before cataract surgery in the general population, there is a growing interest in this topic due to the high prevalence of postoperative DED. A recent randomised controlled trial (RCT) with one month follow-up showed that prophylactic low-level light therapy (LLLT) before and after cataract surgery in patients without pre-existing DED significantly improved postoperative tear film stability, as well as reduced ocular discomfort, compared to no prophylaxis. Apart from LLLT, another light-based treatment for DED is intense pulsed light (IPL); the treatments have shown favourable outcomes in the management of DED, both as stand-alone choices or in combination.
详细描述
Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Cataract surgery, which is one of the most often performed interventions worldwide, can induce or worsen the symptoms of DED. Despite lack of guidelines on DED prophylaxis before cataract surgery in the general population, there is a growing interest in this topic due to the high prevalence of postoperative DED. A recent randomised controlled trial (RCT) with one month follow-up showed that prophylactic low-level light therapy (LLLT) before and after cataract surgery in patients without pre-existing DED significantly improved postoperative tear film stability, as well as reduced ocular discomfort, compared to no prophylaxis. Apart from LLLT, another light-based treatment for DED is intense pulsed light (IPL); the treatments have shown favourable outcomes in the management of DED, both as stand-alone choices or in combination.
There is currently no comparative data available which would allow to choose between LLLT and IPL as prophylaxis for iatrogenic DED after cataract surgery.
The primary objective of this RCT is to compare LLLT versus IPL as prophylaxis for iatrogenic DED after cataract surgery in terms of patient-reported symptoms of eye dryness at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Surgeons and the medical staff (the evaluators) that administer the questionnaires will be blinded to the randomisation, but the orthoptists performing the treatment will be aware of the randomisation. Participants will not be informed of their allocated treatment; however, they may guess which treatment they received as the IPL and LLLT devices look differently, and the patient can see the device being used. Moreover, the patient's experience will be different. In the IPL group, light is administered in pulses and the patients experience heat; furthermore, cooling ultrasound gel and eye patches are used for protection. In the LLLT group, light is administered continuously, and there is no protective gel nor eye patches. At the end of the study, participants may request what type of treatment they received.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥50 years
- •scheduled for bilateral cataract surgery by phacoemulsification
- •without current DED treatment, including eye drops, for at least two months before the inclusion
- •with preoperative OSDI ≤22 points, indicating absence of DED or mild DED
- •who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment
- •affiliated with a social security scheme
- •with an ability to answer questionnaires and to communicate freely in French.
排除标准
- •set to undergo implantation of a multifocal intraocular lens
- •using contact lenses
- •with any of the following in the included eye: (i) age-related macular degeneration (AMD), (ii) previous ocular surgery, (iii) abnormal clinical exam of the ocular surface or (iv) undergoing any ocular treatment
- •with systemic contraindications, including autoimmune diseases (e.g., Sjögren syndrome)
- •with general contraindications for LLLT or IPL treatment: dark pigmented skin (Fitzpatrick grade ≥5), skin photosensitivity (regardless if innate, pathological or medically-induced), or neurological light sensitivity (e.g. epilepsy, light-induced migraines)
- •with contraindications for LLLT or IPL treatment limited to the treatment area: history of skin cancer, skin pigmented lesions, as well as fixed/permanent skin piercings, face tattoos, semi-permanent make-up (including microblading) or skin defects
- •with any concomitant disease or disorder which, in the opinion of the investigator, may put the patient at risk or may influence the result of the study
- •with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
- •who cannot comply with the protocol requirements based on the investigator's judgment.
结局指标
主要结局
Patient-reported symptoms of eye dryness (OSDI)
时间窗: 3 months after cataract surgery
Participants will be asked to report the symptoms of eye dryness by answering an OSDI questionnaire assisted by a member of the medical staff (blinded to the randomisation). OSDI is a widely used, validated questionnaire for the diagnosis of DED and evaluation of its severity and consists of 12 items graded from 0 (never) to 4 (all the time). The final OSDI score is within the range of 0 (no disability) to 100 (complete disability) and is calculated based on the following formula: \[(sum of scores for the questions answered) × 25\] / (total number of questions answered).
次要结局
- Patient-reported symptoms of eye dryness (OSDI)(1 week, 1 month after cataract surgery)
- patient-reported symptoms of eye dryness (SANDE)(1 week after, 1 month after and 3 months after the surgery)
- Non-invasive tear film break-up time (NIBUT)(1 week, 1 and 3 months after cataract surgery)
- Ocular redness(1 week after, 1 and 3 months after cataract surgery)
- Meibomian gland (MG) atrophy(1 week, 1 and 3 months after cataract surgery)
- Fluorescein corneal staining (FCS)(1 week, 1 and 3 months after cataract surgery)
- Eyelid telangiectasias(1 week after, 1 and 3 months after cataract surgery)
- Meibomian expressiblity and quality(1 week, 1 and 3 months after cataract surgery,)
- Ultrasound energy delivered(Intra-operatively)
- Adverse Events(0 to 3 months after cataract surgery)