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CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS

CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04174209
Acronym
RE-CON
Enrollment
52
Registered
2019-11-22
Start date
2019-11-18
Completion date
2020-03-06
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus, Alteration of Visual Acuity

Keywords

Keratoconus, Corneal Topography, Eyeglasses, Ocular Refraction, Jackson Cross Cylinder, Astigmatic Dial Technique, Stenopeic slit

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.

Interventions

BEHAVIORALCylinder

Patients who receive the Jackson Cross Cylinder Method

BEHAVIORALDial

Patients who receive the Astigmatic Dial Technique Method.

BEHAVIORALSlit

Patients who receive the Stenopeic slit Method.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)day 1Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)
Measure of the maximum keratometryday 1value of the point corresponding to the maximum keratometry (called Kmax),
Measure d_Kmaxday 1Measure of the distance between the center and the point of Kmax, (called d\_Kmax)
Measure of keratometry (Km)day 1average value of the keratometry of the 3 central mm called Km
Measure of index of surface varaianceday 1measure of the corneal surface variance index called ISV

Secondary

MeasureTime frameDescription
Subsequent modification of the eyeglasses by the opticianday 30The need (yes / no) for the optician to modify the prescribed spectacle lens (due to poor tolerance)
possible methodday 1The impossibility (yes / no) of carrying out each of the 3 refraction methods.
ametropia valueday 1The values of the final corrective spheres (myopia or hyperopia).
astigmatism axisday 1Collection of the astigmatism axis given by each method, by the autorefractometer and by the corneal topography

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026