Measurement of High Order Aberrations in Late Stages Keratoconus

NCT01295164 | Terminated

• 1 other identifier: 10 214 03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keratoconus

Keywords

keratoconus, wave-front sensing technology, aberrometer

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the study is to evaluate the AOVIS-I and its wave-front sensor with high dynamic range for measuring high-order aberrations in patients with late stages (3 and 4) of keratoconus

  at the 1st day

Secondary Outcomes (2)

• To evaluate the reliability of the measures in early stages (1 and 2) of keratoconus as compared with a "classic aberrometer".

  at the 1st day

• To describe the measures obtained in advanced stages (3 and 4) of keratoconus.

  at the 1st day

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Measurement of aberrations in patients with keratoconus of grade 1

Device: classic aberrometer and aberrometer AOVIS-1

Group 2

ACTIVE COMPARATOR

patients with keratoconus of grade 2

Device: classic aberrometer and aberrometer AOVIS-1

Group 3

EXPERIMENTAL

patients with keratoconus of grade 3

Device: Aberrometer AOVIS-I

Group 4

EXPERIMENTAL

patients with keratoconus of grade 4

Device: Aberrometer AOVIS-I

Interventions

classic aberrometer and aberrometer AOVIS-1 DEVICE

Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a "classic aberrometer".

Group 1; Group 2

Aberrometer AOVIS-I DEVICE

Measurement of aberrations in high stages (3 and 4) of keratoconus. Objective characterization of the optical quality of the patient eye by application of wave-front sensing technology in late stage keratoconus The complete procedure in one patient takes less than 5 minutes in only one consultation and is completely non invasive. The optical measurements only involve the use of low power infrared laser

Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• non keratoconus patients
• patients under 18
• pregnant women or nursing mothers
• ocular infection
• keratitis
• restless patients

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hopstial Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Francois Malecaze, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 14, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)