The study will be conducted on healthy individuals..
Conditions
Interventions
Intervention 1: Intervention group: The intervention group includes eyes that will be randomly fitted with a miniscleral lens filled with preservative-free artificial tears (Artipic Advanced, Iranian
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Healthy individuals aged 18 to 40 years Corrected visual acuity of 10/10 or better in each eye Provide informed consent to participate in the study
Exclusion criteria
Exclusion criteria: History of ocular surgery Systemic or ocular disease Anisometropia Use of systemic or topical medications with visual side effects Known allergy to study eye drops Pregnant or breastfeeding Current smoker Diabetes Physical or mental impairment preventing study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contrast Sensitivity Assessment. Timepoint: Measurement of contrast sensitivity at the start of the study before fitting miniscleral lenses, 30 minutes, 90 minutes, 180 minutes after fitting the lenses, and 5 minutes after lens removal. Method of measurement: CSV-1000 (Vector Vision Co,USA) contrast sensitivity testing chart for measuring contrast sensitivity.;Corneal aberrometry assessment (including total corneal aberrometry, anterior corneal aberrometry, and posterior corneal aberrometry). Timepoint: Corneal aberrometry measurements will be taken at baseline (before lens wear), after three hours of lens wear (after removal of the lens). Method of measurement: Corneal aberrometry will be measured using the Pentacam AXL (Oculus, Germany).;Visual acuity. Timepoint: Visual acuity will be measured prior to the fitting of miniscleral lenses, at 30 minutes, 1.5 hours, and 3 hours post-fitting, and immediately following lens removal at the conclusion of the 3-hour period, using standardized methods. Method of measurement: Visual acuity will be assessed using the Snellen chart, measuring both uncorrected and corrected visual acuity monocularly.;Refractive Changes. Timepoint: Refractive changes will be measured prior to the fitting of miniscleral lenses, at 30 minutes, 1.5 hours, and 3 hours post-fitting, and immediately following lens removal at the conclusion of the 3-hour period, using standardized methods. Method of measurement: Refractive changes will be assessed using an autorefractor for objective refraction and a trial frame with lens set for subjective refraction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale score for assessing comfort, visual fluctuation, foreign body sensation, dryness, grittiness, and burning after using miniscleral lenses. Timepoint: Measurement of Visual Analogue Scale score at the start of the study before fitting miniscleral lenses, 30 minutes, 90 minutes, 180 minutes after fitting the lenses, and 5 minutes after lens removal. Method of measurement: Visual Analogue Scale through direct patient questioning for scoring from 0 to 100 the severity of comfort, visual fluctuation, foreign body sensation, dryness, grittiness, and burning symptoms.;Ocular Surface Disease Index score for evaluating the severity of dry eye symptoms. Timepoint: Measurement of Ocular Surface Disease Index score at the start of the study before fitting miniscleral lenses. Method of measurement: Ocular Surface Disease Index questionnaire for measuring the severity of dry eye symptoms.;Tear Meniscus Height for assessing tear film volume. Timepoint: Measurement of Tear Meniscus Height at the start of the study before fitting miniscleral lenses. Method of measurement: Slit Lamp device for measuring Tear Meniscus Height.;Tear Break-Up Time for assessing tear film stability before using miniscleral lenses. Timepoint: Measurement of Tear Break-Up Time at the start of the study before fitting miniscleral lenses. Method of measurement: Test with Slit Lamp device for measuring Tear Break-Up Time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSamira Hasanzadeh
Mashhad University of Medical Sciences
Outcome results
None listed