Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2018
INTERVENTION: Participants are randomised 1:1:1 by random number generation to one of three groups (the researcher who tests the patients will not know whether they belong to the study group A, study group B, or control group): Treatment for Group A: 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 Treatment for Group B: 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 Treatment for Group C: No Eyepeace or Eye nutrients All participants undergo eye examinations at enrolment, baseline and 3 months after starting treatment. CONDITION: Dry eye ; Eye Diseases ; Other disorders of lacrimal gland PRIMARY OUTCOME: Tear film lipid layer thickness for right and left eyes, measured using images captured with Tearscope at 2 weeks, 1 month, 2 months and 3 months SECONDARY OUTCOME: Measured at baseline, 1 month and 3 months:; 1. Tear film quality, measured as non‐invasive tear break up time using a slit‐lamp‐mounted TearScope on each eye in random order; 2. Meibomian gland function, based upon meibum quality and expressibility using a slit‐lamp following firm digital pressure to the eyelid margins; 3. Ocular redness/hyperaemia, measured using images captured non‐invasively using a high resolution digital slit‐lamp photography of the limbal and temporal conjunctiva for both eyes. Ocular surface conjunctival blood‐flow will also be observed and correlated with the heart beat/pulse of the patient; 4. MMP‐9, an inflammatory marker in the tears of patients with dry eye disease for right and left eyes, measured using a non‐invasive RPS InflammaDry Detector; 5. Corneal sensitivity for right and left eyes, measured using handheld esthesiometer (Cochet‐Bonnet); 6. Corneal staining for right and left eyes, assessed via instillation of lissamine green and fluorescein sodium and using the Oxford corneal grading score; 7. Tear volume for right and left eyes, measured using Phenol red thread test; 8. Dry eye symptoms for right and left eyes, measured using the Ocular Surface Disease Index; 9. Visual satisfaction, measured with Quality of Vision (QOV) questionnaire scores; 10. Longitudinal progress of the patient’s dry eye symptoms and adherence to dry eye treatment, measured with the D‐III questionnaire INCLUSION CRITERIA: 1. Aged 18 or over 2. Have otherwise healthy eyes 3. Are prepared not to wear contact lens for 3 months of the trial 4. Have a NITBUT <10s 5. OSDI score: greater than or equal to 12 6. Symptom frequency at least "some of the time" 7. 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
Epistemonikos ID: bb721798965e9bfd0766683b18cbdddf08ccb06a
First added on: Aug 24, 2024