Clinical trial NCT04422080: Retrospective Observational Study of Posterior Keratometry Measured
Official title: Retrospective Observational Study of Posterior Keratometry Measured by IOLMaster 700 in Patients With Keratoconus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Keywords: Ophthalmology
Keratoconus
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: included all patients having a specialized cornea consultation, in which keratoconus was diagnosed or suspected from November 2018 to May 2020 in the department of Ophthalmology, University Hospital Gui de Chauliac in Montpellier (France),

Brief summary: Keratoconus is a progressive bilateral disease leading to an apical stromal thinning and an irregular astigmatism by a steepening of the cornea, causing visual impairment. The causes are not yet well known, but it seems to be linked to several comorbidities. Keratoconus is a rare and for a long-time asymptomatic condition and its diagnosis needs meticulous screening for the early stages. Detecting it as soon as possible is a goal as it could lead to earlier avoiding of contributing factors such as eye rubbing and earlier treatment if needed.

The gold standard for keratoconus screening and staging is computerized videotography. It gives information about anterior and posterior corneal bulging, steepening, and thinning. It can be completed by anterior segment optical coherence tomography, which can show corneal scarring. Since recently, some biometry devices can give some information about the posterior corneal keratometry trough swept source optical coherence tomography measures. The measurement of the total corneal power instead of an extrapolation lead to better precision in refractive results after cataract surgery in some cases. It also helped to increase our knowledge about posterior corneal astigmatism. In normal eyes, average posterior corneal astigmatism is 0.37 diopters and against the rule in 91 percent of eyes. There is a correlation between the magnitude of anterior and posterior astigmatism.

In keratoconus eyes, several studies have shown that there is an alignment between axes of the anterior and posterior corneal astigmatism. These studies have been performed on computerized videotopography devices.

The goal of this study was to confirm or deny previous observations about posterior astigmatism in keratoconus eyes, and to assess if the rotation of axis between anterior and posterior astigmatism measured by IOL Master 700® can be a good sign for detection of early stages and fruste keratoconus.


Eligibility criteria: Inclusion criteria:

- Keratoconus diagnosed on videotopography

Exclusion criteria:

- loss of sight due to another condition than keratoconus, corneal scarring leading to lack or mistaken data, corneal graft, non-keratoconus related corneal ectasia such as post Laser in Situ Keratomileusis (LASIK) ectasia or keratoglobus

Primary outcomes:
measure: Posterior keratometry
timeFrame: 1 day
Secondary outcomes:
measure: Total keratometry
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Arnaud : MUYL CIPOLLINA, Internship of ophthalmology
role: PRINCIPAL_INVESTIGATOR
References: