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

NCT ID: NCT06069752

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-08

Study Completion Date

2024-03-31

Brief Summary

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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

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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.

Conditions

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Ophthalmological Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carl Zeiss

UNKNOWN

Sponsor Role collaborator

Johannes Kepler University of Linz

OTHER

Sponsor Role lead

Responsible Party

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Matthias Bolz

Univ.-Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Bolz, MD

Role: PRINCIPAL_INVESTIGATOR

JKU Linz

Locations

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Kepler University Hospital

Linz, Upper Austria, Austria

Site Status

Countries

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Austria

References

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Casazza M, Reifeltshammer SA, Hirnschall N, Mariacher S, Laubichler P, Siska R, Wendelstein J, Bolz M. Randomized controlled bilateral comparison of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. BMJ Surg Interv Health Technol. 2025 Jul 10;7(1):e000342. doi: 10.1136/bmjsit-2024-000342. eCollection 2025.

Reference Type DERIVED
PMID: 40662090 (View on PubMed)

Other Identifiers

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KUK-Ophthalmology-003

Identifier Type: -

Identifier Source: org_study_id

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