Astigmatism Clinical Trial
— T30FAOfficial title:
Performance of Total30 for Astigmatism in Digital Device Users
Verified date | April 2024 |
Source | Southern College of Optometry |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users.
Status | Active, not recruiting |
Enrollment | 48 |
Est. completion date | August 18, 2024 |
Est. primary completion date | August 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Adult (18- to 40-year-old) - 0.00 LogMAR visual acuity or better in their habitual CLs or by manifest refraction in both eyes - Smart phone with text messaging capabilities - Existing wearers of soft, frequent replacement toric CLs within past 6 months - Frequent digital device user (e.g., phone, iPad, computer, social media, video streaming, etc.) defined as at least 8 hours of usage per day - Willing to follow the required wear schedule - Astigmatism ranging from 0.75 D to 2.50 D in each eye - Willing to wear their CLs at least 13 hours/day Exclusion Criteria: Have known systemic health conditions that are thought to alter tear film physiology (e.g., Sjögren's syndrome). - Have a known history of being diagnosed with dry eye disease - Have a history of ocular surgery within the past 12 months - Have a history of severe ocular trauma, active ocular infection or inflammation - Have a history of viral eye disease - Currently using isotretinoin-derivatives or ocular medications - Currently using a dry eye treatment including but not limited to artificial tears - Currently using rewetting drops daily or occasionally - If they are pregnant or breast feeding - Need for spectacle add power of any amount (presbyopic) - Currently wearing T30fA CLs - Have a history of wearing hard CLs - Subjects who show excessive lens oscillation with the T30fA lenses during the fitting process yet show 0.0 logMAR acuity, will be excluded from the study. - Patients who report unstable vision while wearing their habitual or study CLs (e.g., rotational instability of CLs) - Willing to not use any artificial tears or dry eye treatments during the study - Willing to not use rewetting drops during the study |
Country | Name | City | State |
---|---|---|---|
United States | Coldwater VIsion Center | Coldwater | Mississippi |
United States | Kannar Eye Care | Pittsburg | Kansas |
Lead Sponsor | Collaborator |
---|---|
Southern College of Optometry | Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) Comfort Scores | Participants will receive text message surveys on which they will record the comfort of their lenses throughout various points in the day, during different periods of the 1 month study. Scores will be recorded on a scale +/- 50 with +50 being the highest level of comfort and -50 being uncomfortable. | Baseline to 1 month of Contact lens wear |
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