The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
low-add multifocal contact lens
standard sphere contact lens
Unnamed facility
North Little Rock, Arkansas, United States
Unnamed facility
Blue Springs, Missouri, United States
Unnamed facility
Lake Ozark, Missouri, United States
Unnamed facility
Warren, Ohio, United States
Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.
Time frame: week 4
Monocular Amplitude of Accommodation
The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.
Time frame: week 4
Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ
Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).
Time frame: week 4
Subject Reported Lens Comfort Using CLUE Questionnaire
Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range from 0 -120.
Time frame: week 4
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Unnamed facility
Kittanning, Pennsylvania, United States
Unnamed facility
Warwick, Rhode Island, United States
Unnamed facility
Chamberlain, South Dakota, United States
Unnamed facility
Burlington, Vermont, United States
Comfortable Wearing Time
Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.
Time frame: week 4
Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper
Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects
Time frame: Baseline