Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients Undergoing Cataract Surgery: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
This randomized, controlled clinical trial investigates the perioperative use of low-level light therapy (LLLT) to prevent or reduce signs and symptoms of dry eye disease (DED) in patients undergoing cataract surgery. DED is a prevalent postoperative complication associated with ocular surface inflammation, meibomian gland dysfunction, and tear film instability, which can compromise visual outcomes and patient satisfaction.
The study enrolled adult patients scheduled for phacoemulsification, with baseline evidence of mild-to-moderate ocular surface disease. Participants were randomly assigned to receive either LLLT via a polychromatic light-emitting mask (Eye-light® ) or a sham device, administered one week before and one week after surgery. The LLLT protocol is designed to photobiomodulate eyelid and periocular tissues to enhance meibomian gland function and reduce subclinical inflammation.
Clinical assessments were conducted at baseline, one week, and six months postoperatively. The primary endpoint was the change in Ocular Surface Disease Index (OSDI) score at one and six months. Secondary endpoints included tear film stability (TBUT), Schirmer I test, corneal staining, tear osmolarity, and tear inflammatory and reparative biomarkers. The study also evaluated the safety and tolerability of the LLLT intervention.
This is the first prospective study assessing the role of perioperative LLLT in mitigating post-cataract ocular surface disease in consecutive patients. The findings may support the integration of LLLT in perioperative ocular surface management protocols.
详细描述
This single-center, randomized, single-masked, parallel-group clinical trial was conducted to evaluate the efficacy and safety of low-level light therapy (LLLT) in the perioperative management of dry eye disease (DED) in patients undergoing cataract surgery. The study was carried out at the Department of Ophthalmology, University of Medicine and Pharmacy "Grigore T. Popa" (Iași, Romania) in accordance with the Declaration of Helsinki and ICH-GCP guidelines.
Dry eye disease is a multifactorial disorder characterized by tear film instability and ocular surface inflammation. Cataract surgery is known to transiently exacerbate or precipitate DED through mechanisms including disruption of corneal nerves, exposure to surgical light and irrigation, and postoperative medication use. This can impair visual rehabilitation and reduce patient satisfaction with surgical outcomes, particularly in individuals with pre-existing ocular surface dysfunction.
LLLT is a non-invasive photobiomodulation technique that delivers low-intensity, polychromatic red and near-infrared light to target mitochondrial cytochromes and promote cellular activity. Its application in ophthalmology has shown potential to improve meibomian gland function, enhance tear film stability, and downregulate inflammatory cytokines on the ocular surface. However, its perioperative utility in cataract surgery has not been formally evaluated.
Eligible participants included consecutive adults (≥18 years) scheduled for phacoemulsification. Key exclusion criteria were a prior diagnosis of ocular surface disease (OSD) or dry eye disease (DED), any history of ocular surgery in either eye, ocular comorbidities, and the current or regular use of topical or instrumental ocular treatments.
Participants were randomized into two groups: the intervention group received LLLT using the Eye-light® device (Espansione Group, Italy), and the control group received sham treatment with an identical, inactive device. Treatments were administered one week before and one week after surgery. The mask delivers light in the 600-1200 nm range through closed eyelids for 15 minutes per session, targeting the periocular region and meibomian glands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive adult patients (aged ≥18 years).
- •Scheduled for routine phacoemulsification cataract surgery.
- •Provided written informed consent and agreed to attend all follow-up visits.
排除标准
- •Prior diagnosis of ocular surface disease (OSD) or dry eye disease (DED).
- •History of ocular surgery in either eye.
- •Presence of ocular comorbidities (e.g., glaucoma, uveitis, corneal dystrophies).
- •Current or regular use of topical ocular treatments such as lubricants, corticosteroids, or cyclosporine.
- •Ongoing or recent instrumental therapies or oral supplements for OSD or DED.
- •Use of systemic medications known to be associated with DED (e.g., diuretics, antidepressants, antihistamines, hormone replacement therapy).
- •History of autoimmune diseases (e.g., Sjögren's syndrome).
- •Regular contact lens wear.
- •Any intraoperative or postoperative complications that could interfere with ocular surface evaluation.
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: Baseline to 6 months after cataract surgery
The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire used to assess the severity of dry eye symptoms and their impact on vision-related functioning. The total score ranges from 0 to 100, with higher scores indicating greater symptom severity. Participants will complete the OSDI questionnaire at baseline, 1 week, 1 month, and 6 months postoperatively. The primary outcome is the change in total OSDI score from baseline to 6 months after surgery, comparing the LLLT group to the sham group.
次要结局
- Tear Film Break-Up Time (TBUT)(Baseline to 6 months after cataract surgery)
- Corneal Fluorescein Staining (CFS)(Baseline to 6 months after cataract surgery)
- Tear Osmolarity(Baseline to 6 months after cataract surgery)
- Tear Inflammatory and Reparative Biomarkers(Baseline to 1 month after cataract surgery)
- Schirmer I Test(Baseline to 6 months after cataract surgery)
研究者
Timofte Zorila Mihaela Madalina
Dr
Grigore T. Popa University of Medicine and Pharmacy