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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01295164
First received: February 9, 2011
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Keratoconus
Device: classic aberrometer and aberrometer AOVIS-1
Device: Aberrometer AOVIS-I
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility of Measurement of High Order Aberrations in Late Stages Keratoconus by Using an Adaptive Optics Visual Simulator AOVIS-I

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 [ Time Frame: at the 1st day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the reliability of the measures in early stages (1 and 2) of keratoconus as compared with a "classic aberrometer". [ Time Frame: at the 1st day ] [ Designated as safety issue: No ]
  • To describe the measures obtained in advanced stages (3 and 4) of keratoconus. [ Time Frame: at the 1st day ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Measurement of aberrations in patients with keratoconus of grade 1
Device: classic aberrometer and aberrometer AOVIS-1
Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a "classic aberrometer".
Active Comparator: Group 2
patients with keratoconus of grade 2
Device: classic aberrometer and aberrometer AOVIS-1
Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a "classic aberrometer".
Experimental: Group 3
patients with keratoconus of grade 3
Device: Aberrometer AOVIS-I
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
Experimental: Group 4
patients with keratoconus of grade 4
Device: Aberrometer AOVIS-I
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295164

Contacts
Contact: Francois Malecaze, Professeur 05 61 77 77 52 ext 33 malecaze.fr@chu-toulouse.fr

Locations
France
University Hopstial Toulouse Recruiting
Toulouse, France, 31000
Contact: Corine Ponchel, Docteur       ponchel.c@chu-toulouse.fr   
Contact: Dyana SEKKAL         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Francois Malecaze, Professeur Toulouse University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01295164     History of Changes
Other Study ID Numbers: 10 214 03, HAO 2010
Study First Received: February 9, 2011
Last Updated: June 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
keratoconus, wave-front sensing technology, aberrometer

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 26, 2014