Clinical trial NCT04987216: PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Europe (PHY2104)
Official title: Multicentric Prospective Post-market Clinical Follow-Up (PMCF) Study to Investigate Clinical Outcomes, Rotational Stability and Patient Reported Outcomes After Implantation of a Monofocal Toric Intraocular Lens (IOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Astigmatism
Keywords: Intraocular Lens
Monofocal
Toric Lens
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: targomedGmbH
First posted: 2021-08-03
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2104)

Detailed description: This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC. The device under investigation is a hydrophobic acrylic monofocal toric intraocular lens (IOL) manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism.

If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be received an implantation with the monofocal parent lens PODEYE.

The study purpose is to determine safety, rotational stability, refractive and visual performance, contrast sensitivity, patient satisfaction and PCO rate after mono- or bilateral implantation of PODEYE TORIC intraocular lens.

In total approx. 30 patients will be recruited for this clinical study and undergo mono- or bilateral implantation of PODEYE TORIC intraocular lens. The maximum time between 1st and 2nd eye implantation is 30 days.

Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 330-420 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days, 330-420 days postoperative visits). Subjects would have the option for unscheduled visits if required medically.

Eligibility criteria: Inclusion Criteria:

* Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes;
* Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs;
* Regular corneal astigmatism (measured by a topographer);
* Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes;
* Capability to understand and sign an IRB approved informed consent form and privacy authorization;
* Clear intraocular media other than cataract;
* Dilated pupil size large enough to visualize IOL axis markings postoperatively;
* Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL implantation;
* Willing and able to conform to the study requirements.

Exclusion Criteria:

* Age of patient \<50 years at the day of screening;
* Regular corneal astigmatism \<0.75 D or \>4.25 D (measured by an automatic keratometer) in both eyes
* Irregular astigmatism (measured by a topographer);
* 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;
* History or presence of macular edema;
* Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
* Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes;
* Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
* Concurrent or previous (within 30 days) participation in another drug or device investigation;
* Clinically significant dry eye as determined by the investigator's judgement;
* Ocular surface disease (clinical symptoms or keratitis);
* Patients showing contraindications as listed in the current Instructions for use (IFU);
* Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).

In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:

* 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.

Primary outcomes:
measure: Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Best Corrected Distance Visual Acuity compared to historical Data
timeFrame: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Change in cylindrical Power of the Eye
timeFrame: Pre-Op, 1 month postoperative, 6 months postoperative, 12 months postoperative
Other outcomes:
measure: Intraocular pressure (IOP) measurement
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Keratometry
timeFrame: Pre-Op, 1 month postoperative, 6 months postoperative
measure: Biometry
timeFrame: Pre-Op
measure: IOL power
timeFrame: during surgery
measure: Target refraction
timeFrame: during surgery
measure: Fundus OCT
timeFrame: Pre-Op, 6 months postoperative
measure: Pupil Size (photopic)
timeFrame: Pre-Op, 6 months postoperative
measure: Pupil Size (mesopic)
timeFrame: Pre-Op, 6 months postoperative
measure: Manifest refraction
timeFrame: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Uncorrected Distance Visual Acuity (UDVA) - monocular
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Uncorrected Distance Visual Acuity (UDVA) - monocular mesopic
timeFrame: 6 months postoperative, 12 months postoperative
measure: Uncorrected Distance Visual Acuity (UDVA) - binocular
timeFrame: 6 months postoperative, 12 months postoperative
measure: Uncorrected Distance Visual Acuity (UDVA) - binocular mesopic
timeFrame: 6 months postoperative, 12 months postoperative
measure: Corrected Distance Visual Acuity (CDVA) - monocular
timeFrame: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Corrected Distance Visual Acuity (CDVA) - monocular mesopic
timeFrame: 6 months postoperative, 12 months postoperative
measure: Corrected Distance Visual Acuity (CDVA) - binocular
timeFrame: 6 months postoperative, 12 months postoperative
measure: Corrected Distance Visual Acuity (CDVA) - binocular mesopic
timeFrame: 6 months postoperative, 12 months postoperative
measure: Binocular Contrast Sensitivity under photopic light conditions
timeFrame: 6 months postoperative, 12 months postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions
timeFrame: 6 months postoperative, 12 months postoperative
measure: Binocular Contrast Sensitivity under photopic light conditions and using a glare source
timeFrame: 6 months postoperative, 12 months postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
timeFrame: 6 months postoperative, 12 months postoperative
measure: Patient reported outcomes, Quality of Vision Questionnaire
timeFrame: Pre-Op, 6 months postoperative
measure: Slitlamp examination - Corneal Status
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Fundus examination with dilated pupil
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - Signs of inflammation
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - Pupillary block
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - Retinal detachment
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - Status of anterior and posterior capsule
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - IOL decentration
timeFrame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - IOL tilt
timeFrame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - IOL discoloration
timeFrame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - IOL opacity
timeFrame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Manual assessment of IOL axis position
timeFrame: within 10 minutes after surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: PCO grading
timeFrame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Halo and Glare Scores (binocular)
timeFrame: Pre-Op, 6 months postoperative
measure: Safety outcomes
timeFrame: Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Medication Revision
timeFrame: Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Locations:
city: Berlin
country: Germany
facility: Augentagesklinik Spreebogen
city: Erding
country: Germany
facility: Augenzentrum Erding
city: Kiel
country: Germany
facility: Augenzentrum ONE
city: Wittenberg
country: Germany
facility: Medicum Wittenberg
Study officials:
affiliation: Augenzentrum ONE, Kiel
name: Detlef Holland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
citation: Kretz FT, Breyer D, Klabe K, Hagen P, Kaymak H, Koss MJ, Gerl M, Mueller M, Gerl RH, Auffarth GU. Clinical Outcomes After Implantation of a Trifocal Toric Intraocular Lens. J Refract Surg. 2015 Aug;31(8):504-10. doi: 10.3928/1081597X-20150622-01.