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Not yet recruiting NCT02512432

INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

No phase Interventional Keratoconus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INTACS.
Who it may be relevant to
Registry conditions: Keratoconus. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • Device INTACS
    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 outcome measures

  • Corneal mapping to measure corneal thickness and steepening [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT02512432 · 150826

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗