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OpenTrials
Completed

NCT Number: NCT04174209

CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cylinder

Behavioral

Patients who receive the Jackson Cross Cylinder Method

DIAL

Behavioral

Patients who receive the Astigmatic Dial Technique Method.

Slit

Behavioral

Patients who receive the Stenopeic slit Method.

Primary outcomes

  1. Measure of keratometry (Km)

    Time frame: day 1

    average value of the keratometry of the 3 central mm called Km

  2. Measure of the maximum keratometry

    Time frame: day 1

    value of the point corresponding to the maximum keratometry (called Kmax),

  3. Measure d_Kmax

    Time frame: day 1

    Measure of the distance between the center and the point of Kmax, (called d_Kmax)

  4. Measure of index of surface varaiance

    Time frame: day 1

    measure of the corneal surface variance index called ISV

  5. Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)

    Time frame: day 1

    Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)

Secondary outcomes

  1. astigmatism axis

    Time frame: day 1

    Collection of the astigmatism axis given by each method, by the autorefractometer and by the corneal topography

  2. Subsequent modification of the eyeglasses by the optician

    Time frame: day 30

    The need (yes / no) for the optician to modify the prescribed spectacle lens (due to poor tolerance)

  3. possible method

    Time frame: day 1

    The impossibility (yes / no) of carrying out each of the 3 refraction methods.

  4. ametropia value

    Time frame: day 1

    The values of the final corrective spheres (myopia or hyperopia).

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: RE-CON

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 22, 2019
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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