Intraocular Lens Calculation Using Artificial Intelligence
ConditionCataract
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorJohannes Kepler University of Linz
About this trial
The aim of this study is to investigate the lens diameter (LD) as a useful parameter in intraocular lens (IOL) power calculation by using several different non-invasive imaging techniques. The aim is to establish an accurate model for lens diameter estimation and subsequently evaluate the influence of the LD on the effective postoperative lens position. The comparability of the different devices in terms of variability between the biometric measurements will also be assessed.
By then combining these two approaches with artificial intelligence, the aim is to develop a new approach to effectively incorporate the LD in IOL power calculation and improve patient's outcome in the long run.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 21 years and older
planned uncomplicated bilateral cataract surgery
availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
ability to consent to the participation in the study
Disqualifiers
multifocal IOL
combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)
PEX, previous ocular surgery, severe trauma or any pathology that could lead to an unstable capsular bag
glaucoma or any other retinal disease that may affect visual acuity significantly
Trial population
The participants will be selected at Kepler University Clinic Linz at the Departement of Ophthalmology and Optometry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Swept-Source Anterior Segment OCT
DeviceDevice: Swept-Source Anterior Segment OCT The CASIA-2 (Tomey, Japan) is a high-resolution swept-source anterior segment OCT with CE certification. The device allows for incomplete visualization of the lens, including the anterior and posterior lens curvature. Device: AS-OCT + Placido disc corneal topography The MS-39 (CSO, Italy) is a non-invasive device that combines Placido topography with OCT-based anterior segment tomography. Device: Wave-front abberomtery The OSIRIS aberrometer is a standard tool for examining corneal aberration and measuring the ocular wavefront. Device: Swept-Source OCT The IOLMaster 700 (Carl Zeiss Meditec, Germany) is a standard swept-source OCT used for eye examinations. Device: AS-OCT The ANTERION (Heidelberg Engineering, Germany) is an anterior segment swept-source OCT. Diagnostic Test: Refraction Subjective Refraction evaluation using the cross-cylinder method
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Study Cohort with MRI1 intervention
Group B: Study cohort without MRI1 intervention
Trial outcomes
Primary outcomes
1
Prediction model to estimate lens diameter with different measurement tools (swept-AS segment OCT; anterior segment-OCT and Placido topography with OCT-based anterior segment tomography; wave-front abberometry; swept-source OCT and optical biometer)
Developing a prediction model to accurately estimate the lens diameter using biometric parameters (swept-source anterior segment Optical Coherence Topography (Casia-2), Placido topography combined with Optical Coherenece Topography-based anterior segment tomography (MS-39), wave-front abberometry (OSIRIS), Swept-Source Optical Coherence Tomography (IOLMaster 700) and anterior segment swept-source OCT (Anterion).
Time frame
preoperatively, 4 and 12 weeks post cataract surgery2
Prediction model to estimate lens diameter with cerebral Magnetic Resonance Imaging
Developing a prediction model to accurately estimate the lens diameter using cerebral Magnetic Resonance Imaging to examine ocular configuration
Time frame
12 weeks post cataract surgerySecondary outcomes
1
IOL calculation concept an artificial intelligence approach
Development of a new IOL calculation concept which includes the lens diameter using an artificial intelligence approach
Time frame
preoperatively, 4 and 12 weeks post cataract surgery2
Different measurement modalities for the biometry of the eye
Comparison of different measurement modalities (swept-source anterior segment Optical Coherence Topography; anterior segment-Optical Coherence Tomography and Placido topography with Optical Coherenece Topography-based anterior segment tomography; wave-front abberometry; swept-source Optical Coherence Tomography and optical biometer) for the biometry of the eye
Time frame
4 and 12 weeks post cataract surgerySponsors and contacts
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Source ClinicalTrials.gov
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