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

N/ANot Yet RecruitingNCT07055022

Clinique Trenel60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

LLLTPROCEDURE

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

IPLPROCEDURE

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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).

Time frame: 3 months after cataract surgery

Secondary Outcomes

Patient-reported symptoms of eye dryness (OSDI)

Time frame: 1 week, 1 month after cataract surgery

patient-reported symptoms of eye dryness (SANDE)

Participants will answer a Symptom Assessment in Dry Eye (SANDE) questionnaire assisted by a member of the medical staff (blinded to the randomisation). SANDE consists of two questions: "How often, on average, do your eyes feel dry and/or irritated?" and "How severe, on average, do you feel your symptoms of dryness and/or irritation are?". The patient answers both of them on a 100-mm horizontal visual analogue scale (VAS). The location of the mark made by the patient for each question is measured in mm from the left-hand side of the 100-mm line. The final score is calculated by multiplying frequency and severity scores and calculating the square root of the result

Time frame: 1 week after, 1 month after and 3 months after the surgery

Non-invasive tear film break-up time (NIBUT)

Automated corneal surface analysis using CA-900 corneal topographer (Topcon Healthcare, Tokyo, Japan)

Time frame: 1 week, 1 and 3 months after cataract surgery

Ocular redness

Automated corneal surface analysis using CA-900 corneal topographer (Topcon Healthcare, Tokyo, Japan), on 0-4 Efron scale, grade 0 corresponding to normal ocular redness; a high quality image is obtained with CA-900 and Efron scale is displayed on the screen for a manual comparison

Time frame: 1 week after, 1 and 3 months after cataract surgery

Meibomian gland (MG) atrophy

a) Automated corneal surface analysis using CA-900 corneal topographer (Topcon Healthcare, Tokyo, Japan), on 1-4 scale, grade 1 corresponding to \<25% of MG atrophy; grade 2: 25% \< atrophy \< 50%; grade 3: 50% \< atrophy \< 75%; grade 4: atrophy \> 75%

Time frame: 1 week, 1 and 3 months after cataract surgery

Fluorescein corneal staining (FCS)

With 0.5% fluorescein (SERB SA, Bruxelles, Belgium) assessed under a slit lamp, on 1-4 scale, grade 1 corresponding to no punctate staining; grade 2: no punctate staining but eye tearing/watering; grade 3: localised punctate staining; grade 4: diffuse punctate staining or staining fused in plaques

Time frame: 1 week, 1 and 3 months after cataract surgery

Eyelid telangiectasias

Assessed under a slit lamp, on 1-4 scale, grade 1 corresponding to no telangiectasias; grade 2: eyelid (skin) or eyelid margin telangiectasias; grade 3: superficial telangiectasias of inferior palpebral conjunctiva; grade 4: deep telangiectasias of inferior palpebral conjunctiva

Time frame: 1 week after, 1 and 3 months after cataract surgery

Meibomian expressiblity and quality

Assessed under a slit lamp, on 1-4 scale, grade 1 corresponding to no MG obstruction, clear and easily expressed meibum; grade 2: cloudy meibum of abnormal viscosity; grade 3: thick, toothpaste-like or filament-like meibum, difficult to express; grade 4: MG obstruction with no meibum expression even under significant pressure

Time frame: 1 week, 1 and 3 months after cataract surgery,

Ultrasound energy delivered

Collected during the cataract surgery as cumulative dissipated energy (CDE), obtained as an automatically calculated value displayed at the end of the surgery on the screen of the phacoemulsification system

Time frame: Intra-operatively

Adverse Events

Including complications and reoperations, specifying the incidence, severity, and relationship to the treatment applied

Time frame: 0 to 3 months after cataract surgery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts