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
Sponsors and collaborators
Clinique Trenel
Lead sponsor
ProSurg
Collaborator