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Not yet recruitingNCT02512432INTACSUpdated May 7, 2024

INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

An interventional study of INTACS in Keratoconus, sponsored by University of California, San Diego. Not yet recruiting. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

Read the detailed description

Use of asymmetrical corneal inserts to reduce or eliminate myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplantation may potentially be deferred.

02

Conditions studied

  • Keratoconus

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03

In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 40 across 205 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 21 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Other
    Keratoconus

    Device: INTACS

Interventions

  • DeviceINTACS

    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.

06

What researchers measure

Primary outcomes

  1. Corneal mapping to measure corneal thickness and steepening

    Corneal Topography

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02512432
Responsible party
Christopher Heichel, MD (Associate Clinical Professor, University of California, San Diego) — Principal investigator
First posted
Jul 30, 2015
Start date
Dec 2025 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Jun 2029 (estimated)
Last update
May 7, 2024

Study contacts

Onnie Parker
Contact
oparker@ucsd.edu
8588224848
Christopher Heichel, MD
principal investigator · University of California, San Diego, Shiley Eye Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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