This was a prospective, randomized, double-blind, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Hydrogel Contact Lens for vision correction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
Vision Correction
Tri-Service General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
The effectiveness of corrected visual acuity
The effectiveness of corrected visual acuity at 3-month. Effectiveness is defined as visual acuities of both eyes correctable to ≥1.0 with contact lens. Effectiveness formula (%): total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %. Definition of total number of subjects enrolled at a given time: the total number of subjects conforming to the PPS criteria and having worn lenses for 3 months.
Time frame: 3 Months
Effectiveness of corrected visual acuity
Effectiveness of corrected visual acuity at 1 week, 1 month and 2 months. The effectiveness (%) is defined as total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %.
Time frame: 1 week, 1 month and 2 months
Average contact lens corrected visual acuity
The mean, standard deviation, median, maximum, minimum, Q1, Q3 and Inter-Quartile Range (IQR) will be calculated for "Lens corrected visual acuity". Comparisons between the Treatment group and Control group will be made.
Time frame: 1 week, 1 month, 2 months and 3 months
Change in diopter (Spherical and cylindrical power of subjective optometry)
The mean, standard deviation, median, maximum, minimum, Q1, Q3 and Inter-Quartile Range (IQR) will be calculated for "power" (the spherical and cylindrical power). Comparisons between the Treatment group and Control group will be made.
Time frame: 1 week, 1 month, 2 months and 3 months
Change in corneal astigmatism (the vertical and horizontal keratometry meridian, the power and axis of astigmatism)
The mean, standard deviation, median, maximum, minimum, Q1, Q3, and Inter-Quartile Range (IQR) will be calculated for "corneal astigmatism" (the vertical and horizontal curvature, the power and axis of astigmatism). Comparisons between the Treatment group and Control group will be made.
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Time frame: 1 week, 1 month, 2 months and 3 months
Lens broken rate
The number and percentage of parameters (total lenses, unbroken lenses, broken lenses) will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made.
Time frame: 1 week, 1 month, 2 months and 3 months
Lens fitting (lens centration, lens movement, coverage, and tightness)
The total number and percentage of parameters (lens centration, lens movement, coverage, tightness) with grading scale evaluated by investigators will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made.
Time frame: 1 week, 1 month, 2 months and 3 months
Subjective acceptance (comfort, vision, lens handling, lens cleaning)
The total number and percentage of parameters (comfort, vision, lens handling, lens cleaning) with a grading scale using questionnaires will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made.
Time frame: 1 week, 1 month, 2 months and 3 months
Lens state (lens front surface wettability, front surface deposits, back surface deposits)
The total number and percentage of parameters (lens front surface wettability, front surface deposits, back surface deposits) with a grading scale evaluated by investigators will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made.
Time frame: 1 week, 1 month, 2 months and 3 months