Study to Optimize the IOL Constant of a New Multifocal Intraocular Lens (HECATE A)

A Prospective, Non-comparative, Multicenter Trial to Optimize the IOL Constant of a New Multifocal IOL

Prospective, non-comparative, multicenter study on medical device with 6 months follow-up.

Study Overview

• Status: Terminated
• Conditions: Cataract Senile
• Intervention / Treatment: Device: trifocal intraocular lens

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• El Salvador
  • San Salvador, El Salvador
    • Clinica Quesada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patient of any gender;
• Patient with clinically significant bilateral age-related cataracts with planned phacoemulsification cataract extraction and suitable for implantation of a posterior chamber trifocal intraocular lens as determined by investigator's medical judgement;
• Projected postoperative corrected distance visual acuity (CDVA) better than 0.2 LogMAR as determined by investigator's medical judgement;
• Preoperative keratometric (corneal) astigmatism ≤1.5 D;
• Clear intraocular media other than cataract;
• Requiring an IOL power within the available range of the investigational IOL (15.0 to +27.0 D, in 0.5 D increments);
• Patient agrees to have surgery of the second eye performed between 1 day and 10 days after the surgery of the first eye.
• Given written informed consent by patient;
• Patient willing and able to comply with examination procedures and schedule for follow-up visits;

Exclusion Criteria:

• Presence of uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.;
• Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, glaucoma (uncontrolled despite intake of medication), macular degeneration;
• Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or oedema as per Investigator's medical judgement; conditions including but not limited to keratitis, keratoconjunctivitis, kerato uveitis, keratopathy, keratectasia;
• Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium etc.);
• Use of and foreseeable use of systemic medications that may confound the outcome or increase the risk to the patient per investigator's medical judgement (e.g., steroids, Tamsulosin Hydrochloride or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g. small pupil/floppy iris syndrome], anti-metabolites, etc.);
• Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to cause future acuity loss to 0.2 LogMAR (CDVA) or worse;
• Patients with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens;
• Patients with previous refractive surgery procedures, including but not limited to LASIK, limbal relaxing incision;
• Planned concomitant ocular procedure during cataract surgery or within the next 6 months (e.g. glaucoma surgery including implantation of MIGS, astigmatic correction surgery, penetrating keratoplasty, laser-assisted in situ keratomileusis);
• Patients who are expected to require retinal laser treatment within the next 6 months per investigator's medical judgement;
• Amblyopia;
• Rubella, congenital, traumatic or complicated cataracts;
• History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis;
• Microphthalmos or macrophthalmos;
• Iris defects (e.g. aniridia);
• Optic nerve atrophy;
• Pseudoexfoliation;
• Keratoconus or irregular astigmatism;
• Inability to measure keratometry or biometry (including but not limited to cataract density, patient unable to focus for longer time etc.);
• Pathologic miosis;
• Pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes;
• Patient whose freedom is impaired by administrative or legal order;
• Concurrent participation in another drug or device investigation that could confound the outcome of this investigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trifocal intraocular lens; Implantation of new trifocal intraocular lens	Device: trifocal intraocular lens; cataract extraction and implantation of a posterior chamber trifocal intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimization of the IOL constant	Optimization of the calculated IOL constant with regression analysis by utilizing the following data measured during the study: Corneal radii, axial length, anterior chamber depth, IOL power, target refraction, manifest refraction and refraction distance	6 months

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2022
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: AT ELANA 841P-BER-301-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No