Astigmatism
Conditions
Brief summary
This is a post-market observational clinical investigation. The objective of this observational study is to evaluate the visual performance and HCP satisfaction of REVIVE samfilcon B custom toric contact lenses.
Interventions
DEVICEREVIVE samfilcon B custom toric contact lenses
REVIVE samfilcon B custom toric contact lenses
Sponsors
Bausch & Lomb Incorporated
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Be 18 years or older on the date the ICF is signed 2. Have the capacity to read, understand, and provide written voluntary informed consent 3. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings 4. Have no active ocular disease or allergic conjunctivitis 5. Not be using any topical ocular medications 6. Be willing and able to follow instructions 7. Have signed a statement of informed consent 8. Be an experienced soft contact lens wearer (have previously used soft contact lenses) 9. Meet the indications per the Instructions for Use (IFU) and have a suitable prescription for treatment with the device
Exclusion criteria
1. Is participating in another research study 2. Is considered by the Investigator to not be a suitable candidate for participation 3. Is not eligible for treatment with the study lens per the IFU (contraindicated) 4. Has had previous ocular surgery 5. Is taking/using ocular, systemic, or topical medications that, in the Investigator's opinion, could potentially affect ocular physiology or lens/solution performance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator overall satisfaction as assessed by the Investigator Survey | Assessed 14 days ± 3 days after the final dispensing/refinement visit | (completed by the Investigator for each subject at 14 days ± 3 days after the final dispensing/refinement visit) |
Countries
United States
Contacts
Primary ContactMarjorie Rah
Backup ContactVictoria Panagakis
Outcome results
None listed