NCT04174209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

March 20, 2020

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

November 20, 2019

Last Update Submit

March 19, 2020

Conditions

KeratoconusAlteration of Visual Acuity

Keywords

KeratoconusCorneal TopographyEyeglassesOcular RefractionJackson Cross CylinderAstigmatic Dial TechniqueStenopeic slit

Outcome Measures

Primary Outcomes (5)

  • Measure of keratometry (Km)

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

    day 1

  • Measure of the maximum keratometry

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

    day 1

  • Measure d_Kmax

    Measure of the distance between the center and the point of Kmax, (called d\_Kmax)

    day 1

  • Measure of index of surface varaiance

    measure of the corneal surface variance index called ISV

    day 1

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

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

    day 1

Secondary Outcomes (4)

  • astigmatism axis

    day 1

  • Subsequent modification of the eyeglasses by the optician

    day 30

  • possible method

    day 1

  • ametropia value

    day 1

Study Arms (1)

Cohort 1

EXPERIMENTAL

70 patients are involved and will perform the three conditions.

Behavioral: CylinderBehavioral: DialBehavioral: Slit

Interventions

CylinderBEHAVIORAL

Patients who receive the Jackson Cross Cylinder Method

Cohort 1
DialBEHAVIORAL

Patients who receive the Astigmatic Dial Technique Method.

Cohort 1
SlitBEHAVIORAL

Patients who receive the Stenopeic slit Method.

Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 34415365DERIVED

MeSH Terms

Conditions

Keratoconus

Interventions

cylindrin

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Frédéric Chiambaretta

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 22, 2019

Study Start

November 18, 2019

Primary Completion

March 6, 2020

Study Completion

March 6, 2020

Last Updated

March 20, 2020

Record last verified: 2019-11

Locations

FR(1)