Measurement of High Order Aberrations in Late Stages Keratoconus (VOPTICA)

Toulouse University Hospital

Status: Terminated

Conditions: Keratoconus

Treatments: Device: Aberrometer AOVIS-I; Device: classic aberrometer and aberrometer AOVIS-1

Study type: Interventional

Funder types: Other

Identifiers

NCT01295164

10 214 03

Details and patient eligibility

About

The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual simulator (AOVIS-I). The system provides an objective characterization of the optical quality of the patient's eye by application of wave-front sensing technology. The optical condition of every eye is represented by its wave aberration. This characterization overcomes the current description based only in refractive errors. This provides an accurate description of the optics of the eye based on the assessment of the whole set of ocular aberrations. The particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as patients with keratoconus.

Full description

The complete procedure in one patient takes less than 5 minutes and is completely non-invasive.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• to be able to understand an information and give a consent
• patients over 18
• patients with keratoconus
• affiliated to medical insurance.

Exclusion criteria

• non keratoconus patients
• patients under 18
• pregnant women or nursing mothers
• ocular surgery 90 days before inclusion
• ocular infection
• keratitis
• restless patients

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Group 1

Active Comparator group

Description:

Measurement of aberrations in patients with keratoconus of grade 1

Treatment:

Device: classic aberrometer and aberrometer AOVIS-1

Group 2

Active Comparator group

Description:

patients with keratoconus of grade 2

Treatment:

Device: classic aberrometer and aberrometer AOVIS-1

Group 3

Experimental group

Description:

patients with keratoconus of grade 3

Treatment:

Device: Aberrometer AOVIS-I

Group 4

Experimental group

Description:

patients with keratoconus of grade 4

Treatment:

Device: Aberrometer AOVIS-I