Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery (Z8_CCI)

Ziemer

Status: Completed

Conditions: Cataract

Treatments: Device: Femtosecond Laser for Cataract Surgery; Other: Conventional Cataract Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT04082273

CPFEM-0005-CH

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Femtosecond Laser for Cataract Surgery

Experimental group

Description:

Capsulotomy, lens fragmentation and Clear Corneal Incisions with FEMTO LDV Z8, followed by ultrasound phacoemulsification and IOL implantation.

Treatment:

Device: Femtosecond Laser for Cataract Surgery

Conventional Cataract Surgery

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Cataract Surgery