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CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS (RE-CON)

Primary Purpose

Keratoconus, Alteration of Visual Acuity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cylinder
Dial
Slit
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Corneal Topography, Eyeglasses, Ocular Refraction, Jackson Cross Cylinder, Astigmatic Dial Technique, Stenopeic slit

Eligibility Criteria

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

Inclusion Criteria:

  • adult persons
  • patients with keratoconus
  • patients with alteration of visual acuity
  • ability to give informed consent to participate in the study
  • affiliation to a social security scheme

Exclusion Criteria:

  • Keratoconus grafted with cornea or with intracorneal rings.
  • Central corneal opacities.
  • Presence of other eye diseases affecting visual acuity.
  • Patients under guardianship, curatorship or justice protection.
  • Pregnant or breastfeeding women.
  • Refusal to participate in the study.

Sites / Locations

  • Chu Clermont Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort 1

Arm Description

70 patients are involved and will perform the three conditions.

Outcomes

Primary Outcome Measures

Measure of keratometry (Km)
average value of the keratometry of the 3 central mm called Km
Measure of the maximum keratometry
value of the point corresponding to the maximum keratometry (called Kmax),
Measure d_Kmax
Measure of the distance between the center and the point of Kmax, (called d_Kmax)
Measure of index of surface varaiance
measure of the corneal surface variance index called ISV
Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)
Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)

Secondary Outcome Measures

astigmatism axis
Collection of the astigmatism axis given by each method, by the autorefractometer and by the corneal topography
Subsequent modification of the eyeglasses by the optician
The need (yes / no) for the optician to modify the prescribed spectacle lens (due to poor tolerance)
possible method
The impossibility (yes / no) of carrying out each of the 3 refraction methods.
ametropia value
The values of the final corrective spheres (myopia or hyperopia).

Full Information

First Posted
November 20, 2019
Last Updated
March 19, 2020
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04174209
Brief Title
CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS
Acronym
RE-CON
Official Title
CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Keratoconus is a rare evolving corneal ectasia that alters visual acuity. To improve spectacle-corrected visual acuity, various subjective refraction techniques can be used. The subjective refraction techniques of keratoconus-carrying patients have never been studied. The main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus. The main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.
Detailed Description
Keratoconus is a rare evolving corneal ectasia that alters visual acuity. To improve spectacle-corrected visual acuity, various subjective refraction techniques can be used. The Jackson Cylinder Cross Method, the Astigmatic Dial Technique and the Stenopeic Slit are three validated subjective refraction techniques for measuring astigmatism. The subjective refraction techniques of keratoconus-carrying patients have never been studied. The main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus. The investigators collect several characteristics of corneal topography of the keratoconus : the average value of the keratometry of the 3 central mm called Km ; the value of the point corresponding to the maximum keratometry (called Kmax), the distance between the center and the point of Kmax, (called d_Kmax) ; the corneal surface variance index called ISV ; the Belin/Ambrósio Enhanced Ectasia Display (called BAD-D). The main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Alteration of Visual Acuity
Keywords
Keratoconus, Corneal Topography, Eyeglasses, Ocular Refraction, Jackson Cross Cylinder, Astigmatic Dial Technique, Stenopeic slit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
70 patients are involved and will perform the three conditions.
Intervention Type
Behavioral
Intervention Name(s)
Cylinder
Intervention Description
Patients who receive the Jackson Cross Cylinder Method
Intervention Type
Behavioral
Intervention Name(s)
Dial
Intervention Description
Patients who receive the Astigmatic Dial Technique Method.
Intervention Type
Behavioral
Intervention Name(s)
Slit
Intervention Description
Patients who receive the Stenopeic slit Method.
Primary Outcome Measure Information:
Title
Measure of keratometry (Km)
Description
average value of the keratometry of the 3 central mm called Km
Time Frame
day 1
Title
Measure of the maximum keratometry
Description
value of the point corresponding to the maximum keratometry (called Kmax),
Time Frame
day 1
Title
Measure d_Kmax
Description
Measure of the distance between the center and the point of Kmax, (called d_Kmax)
Time Frame
day 1
Title
Measure of index of surface varaiance
Description
measure of the corneal surface variance index called ISV
Time Frame
day 1
Title
Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)
Description
Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)
Time Frame
day 1
Secondary Outcome Measure Information:
Title
astigmatism axis
Description
Collection of the astigmatism axis given by each method, by the autorefractometer and by the corneal topography
Time Frame
day 1
Title
Subsequent modification of the eyeglasses by the optician
Description
The need (yes / no) for the optician to modify the prescribed spectacle lens (due to poor tolerance)
Time Frame
day 30
Title
possible method
Description
The impossibility (yes / no) of carrying out each of the 3 refraction methods.
Time Frame
day 1
Title
ametropia value
Description
The values of the final corrective spheres (myopia or hyperopia).
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult persons patients with keratoconus patients with alteration of visual acuity ability to give informed consent to participate in the study affiliation to a social security scheme Exclusion Criteria: Keratoconus grafted with cornea or with intracorneal rings. Central corneal opacities. Presence of other eye diseases affecting visual acuity. Patients under guardianship, curatorship or justice protection. Pregnant or breastfeeding women. Refusal to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Chiambaretta
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34415365
Citation
Metzger M, Navel V, Barriere JV, Kwiatkowski F, Hebraud J, Mulliez A, Beral L, Chiambaretta F, Dutheil F. Benefits of using corneal topography to choose subjective refraction technique in keratoconus (RE-CON): a prospective comparative crossover clinical study. Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):197-207. doi: 10.1007/s00417-021-05382-y. Epub 2021 Aug 20.
Results Reference
derived

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CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS

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