Measurement of High Order Aberrations in Late Stages Keratoconus

Keratoconus Clinical Trial

— VOPTICA  

Official title:

Feasibility of Measurement of High Order Aberrations in Late Stages Keratoconus by Using an Adaptive Optics Visual Simulator AOVIS-I

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01295164
• Other study ID #: 10 214 03
• Status: Terminated
• Phase: N/A
• First received: February 9, 2011
• Last updated: March 1, 2017
• Start date: October 2011
• Est. completion date: November 2012

Study information

• Verified date: March 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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".
• 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

Locations

Country	Name	City	State
France	University Hopstial Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To describe the measures obtained in advanced stages (3 and 4) of keratoconus.		at the 1st day