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Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus

NCT03647046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-03-31

Study results available
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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.

Conditions

  • Keratoconus

Interventions

DEVICE

Customized Scleral Lens

A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens.

Sponsors & Collaborators

  • Ovitz Corporation

    collaborator INDUSTRY

  • Boston Sight

    collaborator OTHER

  • University of Rochester

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2020-01-20
Completion
2020-01-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03647046 on ClinicalTrials.gov