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

Qualifiers

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

Treatments tested in this trial

  • LLLT
  • IPL

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Clinique Trenel

Lead sponsor

ProSurg

Collaborator