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NCT Number: NCT04082273

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augenklinik ORASIS AG

Reinach, Canton of Aargau, 5734, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femtosecond Laser for Cataract Surgery

Device

Cataract Surgery on study eye according to conventional procedure, with the exception of three steps (Capsulotomy, Lens Fragmentation and Clear Corneal Incisions) which are performed with a Femtosecond Laser in the laser treatment group. Equipment uesd for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment

Conventional Cataract Surgery

Other

Cataract surgery will be performed conventionally, this means the clear corneal incisions will be performed manually by a blade, the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification

Primary outcomes

  1. Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by means of corneal topography Galilei G2

    Time frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery

Secondary outcomes

  1. Change from baseline (pre-operative) Higher-order aberrations (HOAs) by means of aberrometry using Galilei G2

    Time frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery

  2. Central corneal thickness (CCT)

    Time frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery

  3. Endothelial cell density (ECD)

    Time frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery

  4. Effective Phacoemulsification Time (EPT)

    Time frame: Baseline = Treatment day

  5. Ultrasound total time (US)

    Time frame: Baseline = Treatment day

  6. Achieved CCI architecture

    Time frame: 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

  7. Intra- and post-operative CCI related complications rate

    Time frame: Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery

  8. FEMTO LDV Z8 OCT auto - detection accuracy

    Time frame: Baseline = Treatment day

    Analyzed on intra-operative Z8 OCT images

Sponsors and collaborators

Lead sponsor

Ziemer Ophthalmic Systems AG

Industry

Registry information

Official study title

A Single Center, Randomized Control Study to Compare Efficacy and Safety of Femto-laser Created Clear Corneal Incisions with Manually Created Clear Corneal Incisions During Cataract Surgery

Acronym: Z8_CCI

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 9, 2019
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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