Low-level Light Therapy Versus Intense Pulsed Light to Prevent Iatrogenic Dry Eye Disease After Cataract Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorClinique Trenel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
LLLT
Procedure/SurgeryPatients 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
IPL
Procedure/SurgeryPatients 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: IPLActive comparator 1 intervention
Group B: LLLTExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
3 months after cataract surgerySecondary 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).
Time frame
1 week, 1 month after cataract surgery2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Clinique Trenel
Lead sponsor
ProSurg
Collaborator
Source ClinicalTrials.gov
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