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Comparison of Three Swept-source Optical Coherence Biometry Devices in Long and Short Eyes

Sponsored by Vienna Institute for Research in Ocular Surgery

About this trial

Last updated 3 years ago

Study ID

Argos

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
21 to 100 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

The aim of the study is to compare the agreement and repeatability of ocular biometric parameters obtained using three swept-source optical coherence tomography (ss-OCT) device (Argos, IOLMaster 700 and ANTERION). This is a prospective, single centre study, that would include a number of 50 eyes of 50 patients, which attend pre-surgical examination. Three measurements per biometry device will be performed on the day of the first eye surgery. The measurements will be performed in a randomised fashion with three ss-OCT devices (IOLMaster 700, Argos and ANTERION). Inclusion criteria are: 40 years or above, age-related cataract, 20 eyes with AL< 22.0 mm and 30 eyes with AL>25.5 mm. Exclusion criteria are: patients with ocular or systemic pathologies that would interfere with the measurements (e.g. dense cataract, corneal pathology, nystagmus). The main outcome of the study will be: the difference (Limits of agreement) between the devices for the following parameters: keratometry (Ks, Kf, Km), CCT (µm), ACD (mm), LT (mm), AL (mm). Secondary outcomes will be: repeatability coefficient and coefficient of variation between the three device, measurement time for each device, and the feasibility for the Argos device.

What are the participation requirements?

Yes

Inclusion Criteria

- Written informed consent

- 21 years old or above

- age-related cataract

- AL<22.5 mm or >25.5 mm (long or short eyes)

No

Exclusion Criteria

- patients with dense cataract (LOCS grading III) or mature cataract

- corneal pathology that would significantly influence biometric measurements

- nystagmus or pathologies that would affect patient fixation

- pregnancy- for women in reproductive age a pregnancy test will be performed.

Locations

Location

Status

Recruiting