Evaluation of the clinical acceptance of soft contact lenses for shortsightedness in adolescents

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: Randomisation is carried out by a standard computer randomisation generator software. Three soft contact lenses (Eni Eye Q Multifocal Contact Lenses for Daily Wear XT1, XT2 and XTC) will be worn in turn for 1 week by each participant in a random order. Each participant attends the clinic on five occasions: the first visit for enrolment, screening and fitting and the other four visits for contact lens dispensing and follow up measurements. CONDITION: Myopia ; Eye Diseases ; Myopia PRIMARY OUTCOME: Visual satisfaction measured using the mean of three questions each recorded on a 0 ‐100 visual analogue scale at each visit (baseline, V1 dispense, V2 10 +/‐ 3 days later, V3 10 +/‐ 3 days later, V4 10 +/‐ 3 days later) SECONDARY OUTCOME: Visual acuity measured using high and low LogMar visual acuity charts at a distance of 4 metres during each visit (baseline, V1 dispense, V2 10 +/‐ 3 days later, V3 10 +/‐ 3 days later, V4 10 +/‐ 3 days later) INCLUSION CRITERIA: 1. Age 10 to 16 years 2. Spectacle refraction: ‐0.75 to ‐6.00D spherical equivalent, maximum anisometropia 1.25D, cylinder up to ‐1.00DC 3. Best corrected visual acuity of at least 20/25 in each eye 4. Parents/guardians and participant have read and understood the Participant Information Sheet 5. Parents/guardians and participant have read, signed and dated the Informed Consent 6. Have normal eyes with the exception of the need for visual correction 7. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Epistemonikos ID: b937b9d77d78e5d29c7dafa5ff387a9ef602c7a2
First added on: Jan 29, 2021