NCT04918316

Brief Summary

Keratoconus is a non-inflammatory, progressive disease in which corneal irregularity increases. As the condition develops, more advanced forms of optical correction are needed to improve vision for patients. Until recently, small diameter corneal gas permeable lenses were considered the primary mode of correction for patients with keratoconus. Now, however, practitioners have multiple options for reducing the optical aberrations caused by keratoconus, including scleral lenses. As of yet, no single option for optical correction has been identified as the preferred mode of correction in terms of overall patient satisfaction with vision, comfort, and ease of use. The order in which various forms of optical correction would be most logically introduced has yet to be determined. This is a study comparing small diameter corneal gas permeable and large diameter scleral lenses in individuals with keratoconus. This study will prospectively compare visual satisfaction and ease of use between corneal gas permeable and scleral lenses for patients with mild to moderate keratoconus.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 23, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

May 14, 2021

Last Update Submit

January 21, 2025

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Final contact lens choice

    Each study participant will select whether to continue with Lens 1 or Lens 2. The percentage of those who choose a Scleral Lens will be compared to the percentage of participants who select corneal gas permeable lenses.

    At study completion (6-24 weeks)

Secondary Outcomes (1)

  • Subjective comfort with lens use

    Baseline, Study Visit 1 (2-4 weeks), Study Visit 2 (4-10 weeks) and at study completion (6-24 weeks)

Study Arms (2)

Corneal gas permeable lens first

ACTIVE COMPARATOR

Device: corneal gas permeable contact lenses (RoseK2 corneal Blanchard Contact Lens, Inc. Manchester, NH). Participants with an odd study ID will be fit with the corneal gas permeable lens first.

Other: Corneal gas permeable lens

Scleral lens first

ACTIVE COMPARATOR

Device: scleral lenses (SynergEyes VS (Synergeyes, Inc., Carlsbad CA). Participants with an even study ID will be fit with the scleral lens first.

Other: Corneal gas permeable lens

Interventions

Corneal gas permeable lensOTHER

Fit in corneal gas permeable contact lens first.

Corneal gas permeable lens firstScleral lens first

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of keratoconus
  • Available baseline corneal topography and pachymetry
  • Amsler-Krumeich keratoconus classification9 of stage 1

You may not qualify if:

  • No prior corneal transplantation or INTACTS
  • No prior use of hybrid, corneal or scleral gas permeable lenses
  • Presence of corneal scarring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Illinois at Chicago Eye and Ear Infirmary

Chicago, Illinois, 60612, United States

Location

Illinois Eye Institute

Chicago, Illinois, 60616, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Ellen S Shorter, OD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Ophthalmology

Study Record Dates

First Submitted

May 14, 2021

First Posted

June 8, 2021

Study Start

July 23, 2021

Primary Completion

April 1, 2025

Study Completion

September 1, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)