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

Ophthalmological Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06069752
• Other study ID #: KUK-Ophthalmology-003
• Status: Active, not recruiting
• Start date: March 8, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: October 2023
• Source: Johannes Kepler University of Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Eye Diseases
• Ophthalmological Disorder

Locations

Country	Name	City	State
Austria	Kepler University Hospital	Linz	Upper Austria

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Kepler University of Linz	Carl Zeiss

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tilt and decentration of intraocular lens measured in degrees	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	1 month post surgery compared with 12 months post surgery