Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens

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

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2024-06-27

Brief Summary

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The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.

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Detailed Description

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This is a staged, multicentric, controlled, prospective, open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device Isatis.

The investigational device, Control lens and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.

The study will be carried out in up to five clinical centers in Spain.

The device under investigation is a hydrophobic acrylic trifocal intraocular lens (IOL) manufactured by the sponsor of this study. The trifocality of this investigational device is based on a purely refractive principle with the goal to provide additional near and intermediate visual acuity with low photic side effects. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development.

The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be implanted during cataract surgery. This control lens is CE approved and commercially available in Spain. Isatis monofocal lens is the parent lens of the device under investigation and both lenses share mechanical and material properties.

In total 180 patients will be recruited for this clinical study and undergo bilateral implantation of the Isatis TF intraocular lens or Isatis lens in a 2:1 ratio. Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 11-13 months. Subjects would have the option for unscheduled visits if required medically.

Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.

Conditions

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Cataract Lens Opacities

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IOL implantation experimental

Experimental arm: Trifocal intraocular lens Isatis TF

Group Type EXPERIMENTAL

Implantation of trifocal IOL, Isatis TF (device under investigation)

Intervention Type DEVICE

Patients will be implanted with study IOL in both eyes

IOL implantation active comparator

Comparator arm: Monofocal intraocular lens Isatis

Group Type ACTIVE_COMPARATOR

Implantation of monofocal IOL, Isatis (control device)

Intervention Type DEVICE

Patients will be implanted with Control IOL in both eyes

Interventions

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Implantation of trifocal IOL, Isatis TF (device under investigation)

Patients will be implanted with study IOL in both eyes

Intervention Type DEVICE

Implantation of monofocal IOL, Isatis (control device)

Patients will be implanted with Control IOL in both eyes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinically documented age-related cataract in both eyes with no comorbidity;
* Calculated IOL power is within the range of the investigational IOLs;
* Male or female adults ages 50 years or older on the day of screening who have cataracts in both eyes;
* Regular corneal astigmatism (measured by topographer)
* Astigmatism ≤1.0 D (measured by an automatic keratometer)
* Clear intraocular media other than cataract;
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
* Signed informed consent.

Exclusion Criteria

* Age of patient \< 50 years;
* Regular corneal astigmatism \>1.0 dioptres (measured by an automatic keratometer)
* Irregular astigmatism (measured by topographer);
* Difficulty for cooperation (distance from their home, general health conditions);
* Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
* Subjects with AMD suspicious eyes as determined by OCT examination;
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
* Ocular hypertension, suspicious glaucoma or glaucoma;
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
* Expected complicated surgery;
* Ocular surface disease (clinical symptoms or keratitis);
* Pregnancy or lactation;
* Second eye treatment will only be performed when Best Corrected Distance Visual Acuity (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal);
* Concurrent participation in another drug or device investigation.

* zonular instability;
* need for iris manipulation;
* capsular fibrosis or other opacity; and
* inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes