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

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ClinicalTrials.gov Identifier: NCT01295164
Recruitment Status : Terminated (Lack of recruitment)
First Posted : February 14, 2011
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Keratoconus Device: classic aberrometer and aberrometer AOVIS-1 Device: Aberrometer AOVIS-I Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 [ Time Frame: at the 1st day ]

Secondary Outcome Measures :
  1. 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 ]
  2. To describe the measures obtained in advanced stages (3 and 4) of keratoconus. [ Time Frame: at the 1st day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295164


Locations
France
University Hopstial Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Francois Malecaze, MD Toulouse University Hospital

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01295164     History of Changes
Other Study ID Numbers: 10 214 03
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases