Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients Undergoing Cataract Surgery

NCT07067294 | Completed DMC

• 1 other identifier: Grigore T. Popa n.54/290724
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye; Meibomian Gland Dysfunction (Disorder); Ocular Surface Disease

Keywords

Dry eye disease; LLLT; Photobiomodulation

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI)

  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.

  Baseline to 6 months after cataract surgery

Secondary Outcomes (5)

• 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

• Schirmer I Test

  Baseline to 6 months after cataract surgery

• Tear Inflammatory and Reparative Biomarkers

  Baseline to 1 month after cataract surgery

Study Arms (2)

LLLT Group

EXPERIMENTAL

A total of 50 patients were randomized to the low-level light therapy (LLLT) group. All participants underwent standard cataract surgery and received two sessions of periocular LLLT using the Eye-light® device (Espansione Group, Italy): one session one week before surgery and another one week after. The treatment was delivered through a wearable mask emitting polychromatic red and near-infrared light, targeting the eyelids and meibomian glands. Of the 50 randomized patients, 3 were lost to follow-up and 2 discontinued the intervention due to postoperative complications. Ultimately, 45 patients completed the full study protocol and were included in the final analysis. Ocular surface assessments were performed at baseline, 1 week, 1 month, and 6 months postoperatively to evaluate the effects of LLLT on tear film quality, inflammation, and meibomian gland function.

Device: Low-Level Light Therapy

Sham Group

SHAM COMPARATOR

A total of 48 patients were randomized to the sham group. These participants underwent standard cataract surgery and received two perioperative sessions of a simulated light-based treatment, one administered one week before and one week after surgery. The procedure mimicked the experience of the active LLLT intervention, using the same mask device without activation of the therapeutic light emission. Of the 48 enrolled participants, 2 were lost to follow-up and 2 discontinued due to postoperative complications. A total of 44 patients completed the full protocol and were included in the final analysis. Clinical assessments were conducted at the same time points as the active treatment group-baseline, 1 week, 1 month, and 6 months postoperatively-to evaluate tear film function, ocular surface condition, and meibomian gland performance.

Device: Sham (No Treatment)

Interventions

Low-Level Light Therapy DEVICE

The intervention consists of non-invasive periocular photobiomodulation using the Eye-light® device (Espansione Group, Italy), which delivers low-level polychromatic red and near-infrared light (600-1200 nm) through a specially designed mask. Participants receive two 15-minute sessions, one 7 days before and one 7 days after cataract surgery. The treatment is designed to stimulate meibomian gland activity, improve tear film stability, reduce ocular surface inflammation. This protocol is unique compared to standard treatments for dry eye because it targets cellular mitochondrial activity to enhance tissue repair and anti-inflammatory effects. It is non-pharmacological, non-contact, and well-tolerated, making it suitable for perioperative application. The light is delivered through closed eyelids, ensuring safety and comfort, and the device used is CE-marked for ophthalmic applications.

LLLT Group

Sham (No Treatment) DEVICE

Sham-treated controls underwent the same procedural setup as the active treatment group, using the Eye-light® device (Espansione Group, Italy). However, instead of delivering therapeutic levels of light energy, the device operated in demo light mode, emitting less than 30% of the full treatment power. This setting simulated the visual and sensory experience of a low-level light therapy (LLLT) session without delivering biologically effective photobiomodulation. The sham intervention included two 15-minute sessions: one administered 7 days before cataract surgery and one 7 days after. This approach allowed for masking of participants and investigators to minimize bias, while ensuring that patients in the control group received no active therapeutic exposure.

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive adult patients (aged ≥18 years).
• Scheduled for routine phacoemulsification cataract surgery.
• Provided written informed consent and agreed to attend all follow-up visits.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

University of Medicine and Pharmacy "Grigore T. Popa" Iași

Iași, Romania

Location

Related Publications (1)

• Timofte-Zorila MM, Lixi F, Vlas N, Troisi M, Ozkan G, Pavel-Tanasa M, Istrate S, Preda C, Coco G, Namazbayeva A, Giannaccare G, Branisteanu DC. Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients Undergoing Cataract Surgery: A Prospective Double-Masked Randomized Controlled Clinical Trial. Ophthalmol Ther. 2025 Oct;14(10):2557-2569. doi: 10.1007/s40123-025-01228-6. Epub 2025 Aug 24.

  PMID: 40849606 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This is a randomized, controlled, single-masked, parallel-group trial. Eligible participants undergoing cataract surgery are randomly assigned in a 1:1 ratio to receive either low-level light therapy (LLLT) or a sham treatment. Interventions are administered perioperatively (1 week before and 1 week after surgery), and all clinical outcomes are assessed at baseline, 1 week, 1 month and 6 months postoperatively. Participants remain in their assigned group for the duration of the study, with no crossover between groups.

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: January 8, 2025
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

RO (1)