Low-level Light Therapy Versus Intense Pulsed Light to Prevent Iatrogenic Dry Eye Disease After Cataract Surgery

NCT07055022 | Not Yet Recruiting

• 1 other identifier: 2025-A00858-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract Surgery; Eye Dryness

Keywords

IPL; LLLT; Intense Pulse Light; Low Level Light Therapy; cataract surgery; phacoemulsification; prophylaxis; prevention; eye dryness; dry eye disease; DED

Outcome Measures

Primary Outcomes (1)

• Patient-reported symptoms of eye dryness (OSDI)

  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).

  3 months after cataract surgery

Secondary Outcomes (10)

• 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

Study Arms (2)

IPL

ACTIVE COMPARATOR

Patients in the IPL group will receive 3 sessions of IPL treatment with OptiClear device (Alma Lasers GmbH, Nuremberg, Germany) at D-7, D+7, and D+30. Each session will comprise 90 homogenously spaced pulses of light (wavelength of 550-650 nm, pulse time 10,12 or 15 ms, pulse repetition rate 1-2 Hz) using an energy density of 8-12 J/cm2 adjusted to Fitzpatrick skin type according to the manufacturer's recommendations. The treatment will be applied to the lower eyelid region. Ultrasound gel, as well as protective eye patches will be used, and the patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies

Procedure: IPL

LLLT

EXPERIMENTAL

Patients in the LLLT group will receive 3 sessions of LLLT treatment with Eye-light device (Espansione Group S.p.A., Bologna, Italy) 7 days before phacoemulsification (D-7), 7 days after phacoemulsification (D+7), and 30 days after phacoemulsification (D+30). Each session will consist of 15 minutes of light treatment using a wavelength of 625±40 nm and maximum power of 10 W (maximal total fluence of 32 J/cm2 ± 20% per session) applied on the periorbital region. The patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies

Procedure: LLLT

Interventions

LLLT PROCEDURE

Patients in the LLLT group will receive 3 sessions of LLLT treatment with Eye-light device (Espansione Group S.p.A., Bologna, Italy) 7 days before phacoemulsification (D-7), 7 days after phacoemulsification (D+7), and 30 days after phacoemulsification (D+30). Each session will consist of 15 minutes of light treatment using a wavelength of 625±40 nm and maximum power of 10 W (maximal total fluence of 32 J/cm2 ± 20% per session) applied on the periorbital region. The patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies

Also known as: Low Level Light Therapy, phototherapy, photobiomodulation, cold laser therapy

LLLT

IPL PROCEDURE

Patients in the IPL group will receive 3 sessions of IPL treatment with OptiClear device (Alma Lasers GmbH, Nuremberg, Germany) at D-7, D+7, and D+30. Each session will comprise 90 homogenously spaced pulses of light (wavelength of 550-650 nm, pulse time 10,12 or 15 ms, pulse repetition rate 1-2 Hz) using an energy density of 8-12 J/cm2 adjusted to Fitzpatrick skin type according to the manufacturer's recommendations. The treatment will be applied to the lower eyelid region. Ultrasound gel, as well as protective eye patches will be used, and the patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies

Also known as: Intense Pulsed Light

IPL

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥50 years
• scheduled for bilateral cataract surgery by phacoemulsification
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Trenel: lead
• ProSurg: collaborator

Study Sites (1)

Clinique Trenel

Sainte-Colombe, 69560, France

Location

MeSH Terms

Conditions

Xerophthalmia; Dry Eye Syndromes

Interventions

Low-Level Light Therapy; Phototherapy; Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics

Central Study Contacts

Mathieu De Bats, MD

CONTACT

04 74 78 38 60; mathieudebats@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised controlled surgeon-blinded, evaluator-blinded monocentric trial in a non-inferiority framework with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)