NCT02512432

Brief Summary

To join established study put on by Addition Technologies, Inc. in the surgical implantation of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Dec 2025

Longer than P75 for not_applicable

Status
not yet 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

Study Progress15%
Dec 2025Jun 2029

First Submitted

Initial submission to the registry

July 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
10.3 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

July 29, 2015

Last Update Submit

May 6, 2024

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Corneal mapping to measure corneal thickness and steepening

    Corneal Topography

    1 year

Study Arms (1)

Keratoconus

OTHER
Device: INTACS

Interventions

INTACSDEVICE

asymmetrical corneal inserts to reduce, or eliminate myopia and astigmatism in patients with keratoconus to decrease dependence on contact lenses and spectacle correction, while potentially deferring need for corneal transplantation.

Keratoconus

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age, or older
  • have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
  • have clear central corneas
  • have a corneal thickness of 450 microns or greater at the proposed incision site
  • have corneal transplantation as the only remaining option to improve their visual function

You may not qualify if:

  • under 21 years of age
  • have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
  • do not have clear central corneas
  • do not have a corneal thickness of 450 microns or greater at the proposed incision site
  • do not have corneal transplantation as the only remaining option to improve their visual function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Christopher Heichel, MD

    University of California, San Diego, Shiley Eye Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Onnie Parker

CONTACT

8588224848oparker@ucsd.edu

Study Design

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

Study Record Dates

First Submitted

July 29, 2015

First Posted

July 30, 2015

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

May 7, 2024

Record last verified: 2024-05