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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06069752

Enrollment

Registered

2023-10-06

Start date

2022-03-08

Completion date

2024-03-31

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ophthalmological Disorder

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tilt and decentration of intraocular lens measured in degrees	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

Countries

Austria

Outcome results