CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS
NCT ID: NCT04174209
Last Updated: 2020-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2019-11-18
2020-03-06
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
70 patients are involved and will perform the three conditions.
Cylinder
Patients who receive the Jackson Cross Cylinder Method
Dial
Patients who receive the Astigmatic Dial Technique Method.
Slit
Patients who receive the Stenopeic slit Method.
Interventions
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Cylinder
Patients who receive the Jackson Cross Cylinder Method
Dial
Patients who receive the Astigmatic Dial Technique Method.
Slit
Patients who receive the Stenopeic slit Method.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Frédéric Chiambaretta
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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Chu Clermont Ferrand
Clermont-Ferrand, , France
Countries
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References
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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.
Other Identifiers
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2019-A01624-53
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP 2019 CHIAMBARETTA
Identifier Type: -
Identifier Source: org_study_id
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