ISRCTN11797545.

Trial name or title	Public title: evaluation of combined Eyepeace and Eye Nutrients study Scientific title: Investigate the improvements in tear film/ocular surface and visual recovery in laser and intraocular lens (IOL) refractive surgery patients preoperative using the Eyepeace (Eyelid massager) and Eye Nutrients (omega fatty acid supplement)
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): not reported Number randomized (total and per group): 225 participants (planned) Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): not reported Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Participant characteristics Country: United Kingdom Age (mean ± SD, range): 18 years of age or older (planned) Gender: both (planned) Inclusion criteria: aged 18 or overHave otherwise healthy eyes; are prepared not to wear contact lens for 3 months of the trial; have a NITBUT <10s; OSDI score: greater than or equal to 12; symptom frequency at least "some of the time"; presence of cloudy fluid expressed from at least 1 of the central 8 glands on the lower/upper lid and/or presence of poor expressibility from at least 2‐3 of the central 8 glands on the lower lid Exclusion criteria: conjunctivitis; meibomian cysts; styes; damage to the cornea; ocular injury; cataract or laser refractive surgery in the past 6 months; increased intraocular pressure (primary or secondary); any chronic disease of the eye Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: Eyepeace eyelid massage: once a day, to be started 1 week prior to laser or intraocular lens surgery, to be stopped one day prior to surgery eye nutrients: two capsules a day, to be started 1 week prior to laser or intraocular lens surgery, to be stopped 3 months after surgery Intervention #2: eye nutrients: two capsules a day, to be started 1 week prior to laser or intraocular lens surgery, to be stopped 3 months after surgery Intervention #3: no Eyepeace or eye nutrients Length of follow‐up: 3 months Notes: none
Outcomes	Primary outcome(s): tear film lipid layer thickness Secondary outcome(s): TBUT; meibomian gland function; ocular redness/hyperaemia; MMP‐9; corneal sensitivity; corneal staining; tear volume; dry eye symptoms; visual satisfaction; longitudinal progress of the patient’s dry eye symptoms and adherence to dry eye treatment, Adverse events reported? (Y/N): not reported Measurement time points (specify intervals at which outcomes were assessed):2 weeks, 1 month, 2 months and 3 months Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	March 2018
Contact information	Proffesor Jonathan Moore Cathedral Eye Clinic 89‐91 Academy Street, Belfast, BT1 2LS, United Kingdom
Notes	Date of last participant enrollment: April 1, 2018 Date clinical trial registry last updated: February 13, 2018 Recruitment status: no longer recruiting Other notes: study sponsored by Cathedral Eye Research