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OpenTrials
Completed

NCT Number: NCT04422080

Retrospective Observational Study of Posterior Keratometry Measured

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UH Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Posterior keratometry

    Time frame: 1 day

    Posterior cylinder and axis measured on biometry

Secondary outcomes

  1. Total keratometry

    Time frame: 1 day

    Total corneal power (cylinder and axis) measured on biometrycompleted by the patient

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Retrospective Observational Study of Posterior Keratometry Measured by IOLMaster 700 in Patients With Keratoconus

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
Jun 9, 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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