Clinical Study - ES 900 - 2020-1

NCT05304182 | Unknown

• 1 other identifier: 1023703
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

EYESTAR 900 is a device developed by Haag-Streit which utilises 3D OCT for quantitative measurements of the geometry of the entire eye, including ocular biometry and corneal topography. It is the most recent in a series of successful biometry devices by Haag-Streit (HS Pachymeter, Lenstar LS 900, LS 900 T-cone and LS 900 APS) and also allows for advanced corneal tomography examinations. The EYESTAR 900 is CE marked. These measurement results of this device are used for the planning of the medical treatment of patients. Depending on the application, the benefits of this device may include improved visual acuity (after cataract surgery), reduced risk of complications (after refractive surgery or implant of a phakic intraocular lens), early identification of pathological deformations of the cornea (keratoconus detection). The primary objective of this clinical trial is to assess the clinical performance of the investigational device in dense cataracts. To that end, for each measurand, the in-vivo repeatability will be quantified, as well as limits of agreement and the mean measurement deviation, with respect to the current gold standard device. As a secondary objective of the study, raw measurement data will be collected to allow for the improvement of existing algorithms, development of additional measurands and for retrospective analysis. No diseases are studied.

Conditions

Cataract

Keywords

Optical Biometry; Corneal Topography

Outcome Measures

Primary Outcomes (1)

• Dense Cataract Performance

  The primary outcome is the performance of the EYESTAR 900 in dense cataracts. Specifically, the highest grade of cataract at which complete measurements can reliably be performed and, consequently, the number of patients measured successfully.

  18 months

Secondary Outcomes (12)

• Keratometry

  18 months

• Axial Length

  18 months

• White-to-White Imaging

  18 months

• Anterior Corneal Elevation

  18 months

• Anterior Corneal Axial Curvature

  18 months

Study Arms (2)

Pre-Op

EXPERIMENTAL

The experimental intervention is non-invasive optical imaging, in particular digital photography and optical coherence tomography, conducted with the investigational and comparator device, for the purpose of measuring dimensions of the eye.

Device: EYESTAR 900; Device: LENSTAR LS 900

Post-Op

ACTIVE COMPARATOR

The experimental intervention is non-invasive optical imaging, in particular digital photography and optical coherence tomography, conducted with the investigational and comparator device, for the purpose of measuring dimensions of the eye.

Device: EYESTAR 900; Device: LENSTAR LS 900

Interventions

EYESTAR 900 DEVICE

The EYESTAR 900 is a device developed by Haag-Streit which utilises 3D OCT for quantitative measurements of the geometry of the entire eye, including ocular biometry and corneal topography. It is the most recent in a series of successful biometry devices by Haag-Streit (HS Pachymeter, Lenstar LS 900, LS 900 T-cone and LS 900 APS) and also allows for advanced corneal tomography examinations.

Also known as: Optical Biometer

Post-Op; Pre-Op

LENSTAR LS 900 DEVICE

The LENSTAR LS 900 is a non-contact device for measurement of biometrical parameters of the eye, aimed to assist the calculation of intraocular lenses (IOLs) prior to intraocular lens implantation. The most common application is in preparation of cataract surgery. This device uses OLCR (optical low-coherence reflectometry), an interferometric method to measure intraocular axial distances. Furthermore, it uses digital photography of the anterior section of the eye to measure pupil size and location, as well as the white-to-white distance of the eye. The same photographic unit, in conjunction with a specific illumination pattern, is used to measure the corneal curvature - this measurement is known as 'keratometry', or, more specifically, 'automated keratometry'.

Also known as: Optical Biometer

Post-Op; Pre-Op

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• voluntary participation
• informed consent
• years of age or older

You may not qualify if:

• ineligibility for cataract surgery for any reason, e.g., aphakia
• Disqualifying pathologies:
• keratoconus
• corneal astigmatism of more than 3.5 D
• history of recurrent inflammation or infection of the eye
• Disqualifying corneal conditions:
• comorbidities,
• deformations,
• lesions, or
• scarring of the cornea
• acute inflammation or infection of the eye
• Disqualifying treatments:
• previous refractive surgeries, including PRK and LASIK
• previous corneal surgeries
• previous corneal transplants

Sponsors & Collaborators

• Haag-Streit AG: lead
• Aravind Eye Hospitals, India: collaborator

Study Sites (1)

Aravind Eye Hospitals

Chennai, Tamil Nadu, 600077, India

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Haripriya Aravind, MD

  Aravind Eye Hospitals

  PRINCIPAL INVESTIGATOR

• Thomas Beutler, Dipl. Ing.

  Haag-Streit AG

  STUDY DIRECTOR

• Julian Kool van Langenberghe, ing.

  Haag-Streit AG

  STUDY CHAIR

Central Study Contacts

Rachit Bhandary

CONTACT

+91 40 24891250; rachit@biomedixdevices.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There are two identical arms in this study: pre-operative and post-operative. Every participant starts in the pre-operative arm and crosses over to the post-operative arm. During both arms, each study subject undergoes the experimental intervention and the control intervention. The study objective is to assess the clinical performance of the investigational device. This assessment is performed by a statistical analysis of the measurement results from the experimental intervention and the control intervention. The surgery is not a study intervention.

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: July 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: February 28, 2024
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)