Tilt Prediction of Clareon Intraocular Lens

NCT06595693 | Completed DMC

• 1 other identifier: JKU-Ophthalmology-001
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Misalignment of intraocular lenses can cause severe loss of visual quality. Different types of misalignments are known. Tilt, one type of intraocular lens misalignment is thought to play a negative role for the optical performance in eyes with intraocular designs, especially, if they have aspheric, toric, or multifocal optics. Various methods to measure intraocular lens misalignments have been described. The most recently developed method for tilt quantification is the use of optical coherence tomography. This method has several advantages compared to the previous methods: optical coherence tomography based devices are available in most clinics, the resolution of modern optical coherence tomography devices is high, and the measurements are reproducible.

Conditions

Cataract

Keywords

Intraocular Lens; tilt; cataract

Outcome Measures

Primary Outcomes (1)

• post operative intraocular lens tilt in degrees measured between three different OCT based devices

  amount of tilt of intraocular lens post cataract surgery

  8 weeks post cataract surgery

Secondary Outcomes (3)

• orientation of post operative tilt in degrees measured between three different OCT based devices

  8 weeks post cataract surgery

• decentration of intraocular lens in millimeter measured between three different OCT based devices

  8 weeks post cataract surgery

• distance corrected visual acuity in logMAR

  8 weeks post cataract surgery

Other Outcomes (1)

• visual acuity in logMAR in a subgroup of eyes

  8 weeks post cataract surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with planned cataract surgery of both eyes

You may qualify if:

• Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
• Ability to consent to the participation in the study;
• Signed informed consent

You may not qualify if:

• Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)
• Best corrected distance visual acuity below 0.1 Snellen before surgery
• Pathologies that could have an influence on the post-operative tilt, such as pseudoexfoliation syndrome or previous ophthalmic trauma, or other reasons for phakodonesis
• Previous ophthalmic surgery that could have an influence on post-operative tilt, such as pars plana vitrectomy
• Pregnancy (pregnancy test will be taken preoperatively)

Sponsors & Collaborators

• Johannes Kepler University of Linz: lead

Study Sites (1)

Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria

Linz, Upper Austria, 4020, Austria

Location

Related Publications (1)

• Waser K, Strassmair K, Pomberger L, Khalil H, Laubichler P, Bolz M, Hirnschall N. Capsular Bag Performance of a Novel Hydrophobic Single-Piece Intraocular Lens. Ophthalmol Ther. 2025 Feb;14(2):295-308. doi: 10.1007/s40123-024-01075-x. Epub 2024 Dec 12.

  PMID: 39666249 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Nino Hirnschall, MD

  JKU Linz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: May 23, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 29, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)