N/A
Completed N=12
Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus
Source: ClinicalTrials.gov NCT03647046 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Number of Participants With Normal Vision — 8 Participants
Summary
The goal of the study is to examine the effects of custom front-surface wavefront correction on visual performance, and on neutralization of higher order aberrations, in patients wearing a scleral lens device. The investigators will study patients with keratoconus, the most common type of corneal ectasia, who have already been fitted with the BostonSight BSS (Boston Sight Scleral) for improved visual function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Normal Vision |
8 | — |
Eligibility Criteria
A person will be included in the study if he/she:
- Is 18 years or older and has full legal capacity to volunteer.
- Has been diagnosed with Keratoconus;
- Has no other active ocular disease;
- Is currently wearing the BostonSight BSS in at least one eye ;
- Has non-spherical BostonSight BSS haptic design in the study eye;
- Has 20/400 or better best corrected visual acuity with pinhole 20/60 or better in the study eye;
- Is not pregnant or nursing;
- Has voluntarily agreed to participate in the study by signing the statement of informed consent;
A person will be excluded from the study if he/she:
- Is under the age of 18;
- Has best corrected visual acuity outside 20/400;
- Pregnant or nursing at the time of enrollment in the study;
Data sourced from ClinicalTrials.gov (NCT03647046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.