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NCT Number: NCT02512432

INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Intacs

Device

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.

Primary outcomes

  1. Corneal mapping to measure corneal thickness and steepening

    Time frame: 1 year

    Corneal Topography

Study contacts

Contact information is provided by the study sponsor or research team.

Onnie Parker

CONTACT

[email protected]

8588224848

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: INTACS

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 30, 2015
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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