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

Primary Purpose

Keratoconus

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
classic aberrometer and aberrometer AOVIS-1
Aberrometer AOVIS-I
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Keratoconus focused on measuring keratoconus, wave-front sensing technology, aberrometer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hopstial Toulouse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Measurement of aberrations in patients with keratoconus of grade 1

patients with keratoconus of grade 2

patients with keratoconus of grade 3

patients with keratoconus of grade 4

Outcomes

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

Secondary Outcome Measures

To evaluate the reliability of the measures in early stages (1 and 2) of keratoconus as compared with a "classic aberrometer".
To describe the measures obtained in advanced stages (3 and 4) of keratoconus.

Full Information

First Posted
February 9, 2011
Last Updated
March 1, 2017
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT01295164
Brief Title
Measurement of High Order Aberrations in Late Stages Keratoconus
Acronym
VOPTICA
Official Title
Feasibility of Measurement of High Order Aberrations in Late Stages Keratoconus by Using an Adaptive Optics Visual Simulator AOVIS-I
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
keratoconus, wave-front sensing technology, aberrometer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Measurement of aberrations in patients with keratoconus of grade 1
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
patients with keratoconus of grade 2
Arm Title
Group 3
Arm Type
Experimental
Arm Description
patients with keratoconus of grade 3
Arm Title
Group 4
Arm Type
Experimental
Arm Description
patients with keratoconus of grade 4
Intervention Type
Device
Intervention Name(s)
classic aberrometer and aberrometer AOVIS-1
Intervention Description
Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a "classic aberrometer".
Intervention Type
Device
Intervention Name(s)
Aberrometer AOVIS-I
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
To describe the measures obtained in advanced stages (3 and 4) of keratoconus.
Time Frame
at the 1st day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Malecaze, MD
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hopstial Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Measurement of High Order Aberrations in Late Stages Keratoconus

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