Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Femtosecond Laser for Cataract Surgery; Other: Conventional Cataract Surgery

• Registration Number: NCT04082273
• Lead Sponsor: Ziemer Ophthalmic Systems AG

Brief Summary

The aim of this study is to test the hypothesis, that in terms of Surgically Induced corneal Astigmatism (SIA), Higher-order Aberrations (HOA), and wound geometry the femtosecond clear corneal incisions (CCIs) created during cataract surgery are not inferior when compared to manual CCIs.

The potential risks associated with application of the femtosecond laser in this study are no greater or in most cases less than those associated with the standard manual cataract surgical procedure, and the potential benefits (such as precision and reproducibility) are greater than with the standard manual cataract surgery. Therefore, the risk-to-benefit ratio is very low, such that the potential benefits for a subject participating in this study exceed the potential risks

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-26
• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Status Verified: 2021-07
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation
• Able to co-operate with the docking system for the femtosecond laser
• Clear corneal media
• 40 years of age or older
• Willing and able to return for scheduled follow-up examinations

Exclusion Criteria

• Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea
• Maximum K-value that exceeds 58.D
• Minimal K-value of less than 37.D
• Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
• Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
• Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation
• Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
• Known sensitivity to planned concomitant medications
• History of lens or zonular instability
• Keratoconus or keratectasia
• Immune compromised or diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study Pl.
• Anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured from the corneal endothelium.
• Extensive corneal scarring, pterygium
• Developmental disability or cognitive impairment (would preclude adequate comprehension of the IC form and/or the ability to record the study measurements)
• Concurrent participation in another ophthalmological clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femtosecond Laser for Cataract Surgery	Femtosecond Laser for Cataract Surgery	Capsulotomy, lens fragmentation and Clear Corneal Incisions with FEMTO LDV Z8, followed by ultrasound phacoemulsification and IOL implantation.
Conventional Cataract Surgery	Conventional Cataract Surgery	Clear Corneal Incisions, conventional capsulorhexis and ultrasound phacoemulsification and IOL implantation. Control treatment where the clear corneal incisions and capsulorhexis are performed manually and the lens fragmentation is performed with the phacoemulsification device.

Primary Outcome Measures

Name	Time	Method
Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by means of corneal topography Galilei G2	Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Change from baseline (pre-operative) Higher-order aberrations (HOAs) by means of aberrometry using Galilei G2	Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
Central corneal thickness (CCT)	Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Endothelial cell density (ECD)	Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Effective Phacoemulsification Time (EPT)	Baseline = Treatment day
Ultrasound total time (US)	Baseline = Treatment day
Achieved CCI architecture	1 day postoperative and 12 days postoperative	Presence of Descemet membrane detachment, posterior and anterior wound gape, if present size) will be analyzed on OCT images
Intra- and post-operative CCI related complications rate	Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
FEMTO LDV Z8 OCT auto - detection accuracy	Baseline = Treatment day	Analyzed on intra-operative Z8 OCT images

Trial Locations

Locations (1)

Augenklinik ORASIS AG; 🇨🇭 Reinach AG, Aargau, Switzerland