NCT03647046

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 31, 2020

Completed
Last Updated

March 31, 2020

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

August 23, 2018

Results QC Date

February 11, 2020

Last Update Submit

March 18, 2020

Conditions

Keratoconus

Keywords

Keratoconus, scleral lens

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Normal Vision

    Vision will be tested using the Basic Snellen Visual Acuity test and normal vision will be defined as 20/20.

    30 minutes

Study Arms (1)

Customized Scleral Lens

EXPERIMENTAL

A customized scleral lens will be compared with a non-customized scleral lens in subjects with Keratoconus through vision tests.

Device: Customized Scleral Lens

Interventions

Customized Scleral LensDEVICE

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

Customized Scleral Lens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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;

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Flaum Eye Institute, University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Results Point of Contact

Title
Study Coordinator
Organization
University of Rochester
keratoconusstudy@gmail.com
(585) 276-6922

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 27, 2018

Study Start

October 8, 2018

Primary Completion

January 20, 2020

Study Completion

January 20, 2020

Last Updated

March 31, 2020

Results First Posted

March 31, 2020

Record last verified: 2019-12

Locations

US(1)