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

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Keratoconus
Alteration of Visual Acuity

Treatments

Behavioral: Cylinder
Behavioral: Slit
Behavioral: Dial

Study type

Interventional

Funder types

Other

Identifiers

NCT04174209
RBHP 2019 CHIAMBARETTA
2019-A01624-53 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 1 patient group

Cohort 1
Experimental group
Description:
70 patients are involved and will perform the three conditions.
Treatment:
Behavioral: Dial
Behavioral: Cylinder
Behavioral: Slit

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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