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OpenTrials
Completed

NCT Number: NCT06069752

Positional Stability and Refractive Behaviour After Implantation of an IOL After Cataract Surgery

The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability.

In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

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Key information

Conditions

Ophthalmological Disorder Eye Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kepler University Hospital

Linz, Upper Austria, 4021, Austria

About this study

In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

Furthermore, the refractive outcome of CT Lucia 621P/PY is examined, providing optimized (en bloc optimization) formula constants for both, conventional and femtosecond-laser assisted cataract surgery for Haigis, Hoffer Q, Holladay I, SRK/T and Castrop formulae.

Besides ACD, further parameters for IOL stability are examined (IOL tilt/decentration) and consequences for the aberration profile are described.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult subject with a minimum age of 22 years
  • Planned natural lens replacement with posterior chamber IOL implantation
  • Clear intraocular media other than cataract
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit
  • Ability to consent to the participation in study
  • Signed informed consent

Exclusion criteria

  • Corneal pathology/ectasia
  • Prior ophthalmic surgery
  • Zonular-defects, unstable bag
  • Macular pathologies
  • Expected Visual acuity of less than 0.63 (decimal)
  • Glaucoma
  • Use of systemic or ocular medication that might affect vision
  • Patient is pregnant, plans to become pregnant, is lactating
  • Concurrent participation in any other clinical trial with an investigation product

Treatment and study plan

Primary outcomes

  1. Tilt and decentration of intraocular lens measured in degrees

    Time frame: 1 month post surgery compared with 12 months post surgery

    Tilt and decentration of intraocular lens measured in degrees with Casia-2 Anterior Segment Optical Coherence Tomography 1 month post surgery compared with 12 months post surgery

Sponsors and collaborators

Lead sponsor

Johannes Kepler University of Linz

Other

Collaborators

  • Carl Zeiss Meditec, Inc.

Registry information

Official study title

Positional Stability and Refractive Behaviour After In-the-bag Implantation of an Aspheric Hydrophobic IOL After Conventional Phacoemulsification and Femtosecond Laser-Assisted Cataract Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 6, 2023
Registry last updated
May 16, 2025

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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