Clinical trial NCT03844828: Clinical Study to Investigate Outcomes of Trifocal Toric IOL POD FT in Asian Eyes
Official title: Clinical Study to Investigate Rotational Stability, Visual Performance, Contrast Sensitivity, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Toric IOL
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cataract
Lens Opacities
Presbyopia
Keywords: Intraocular Lens
Trifocal
Toric Lens
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, controlled, single-surgeon, single-center clinical study to compare visual acuity outcomes to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425)

Detailed description: This is a prospective, controlled, single-surgeon, single-center clinical study, whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of trifocal toric intraocular lenses POD FT. The study is aimed to compare visual acuity outcomes the FineVision POD FT IOL to data obtained in a similar study by the same principal investigator on the trifocal FineVision POD F IOL (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425), whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the FineVision POD FT IOL in both eyes or, in case the corneal astigmatism in one of the two eyes of the same patient is too small to implant a toric lens, the FineVision POD F IOL will be implanted in this eye (both lenses: PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD FT and POD F) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The main difference between the lenses is that that the POD FT IOL is the toric version of the POD F IOL. The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 11 study visits (1 preoperative, 2 operative and 8 postoperative) over a period of 24 months. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 6 months follow up visit and secondary endpoint data will be collected at the 1 Day, 1 Week, 1 month, 6, 12 and 24 months postoperative visits. Data analyses will be done after the last patient finished the final examination to support the study publication plan

Eligibility criteria: Inclusion Criteria:

* Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia;
* Regular corneal astigmatism ≥0.75 dioptres (measured by an automatic keratometer or biometer) 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;
* Calculated IOL power is within the range of the study IOLs;
* Dilated pupil size large enough to visualize IOL axis markings postoperatively;
* Willing and able to conform to the study requirements.

Exclusion Criteria:

* Regular corneal astigmatism \<0.75 dioptres (measured by an automatic keratometer or biometer) in both eyes
* Irregular astigmatism;
* Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
* Subjects with AMD suspicious eyes as determined by OCT examination;
* Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* History or presence of macular edema;
* 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;
* Instability of keratometry or biometry measurements;
* Ocular hypertension or glaucoma;
* Significant dry eye;
* Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).

Primary outcomes:
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
timeFrame: 6 months (120-180 days) postoperative
Secondary outcomes:
measure: Manifested refraction
timeFrame: Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Pupil Size
timeFrame: 6 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, 24 months postoperative
measure: Uncorrected Distance Visual Acuity (UDVA) - binocular
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Corrected Distance Visual Acuity (CDVA) - monocular
timeFrame: Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Corrected Distance Visual Acuity (CDVA) - binocular
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular
timeFrame: 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular
timeFrame: 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular mesopic.
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Uncorrected Near Visual Acuity at 35cm (UNVA) - monocular
timeFrame: 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Uncorrected Near Visual Acuity at 35cm (UNVA) - binocular
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
timeFrame: 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular mesopic
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Defocus Curve
timeFrame: 6 months postoperative
measure: Binocular Contrast Sensitivity under photopic light conditions
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
timeFrame: 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Patient reported outcomes
timeFrame: 6 months postoperative, 12 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, 24 months postoperative
measure: Fundus examination with dilated pupil
timeFrame: Pre-OP, 1 month 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, 24 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, 24 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, 24 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, 24 months postoperative
measure: Slitlamp examination - IOL decentration
timeFrame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Slitlamp examination - IOL tilt
timeFrame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Slitlamp examination - IOL discoloration
timeFrame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Slitlamp examination - IOL opacity
timeFrame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Photograph of IOL with dilated pupil to asses IOL rotation
timeFrame: OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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, 24 months postoperative
measure: Keratometry
timeFrame: Pre-OP
measure: Biometry
timeFrame: Pre-OP
measure: IOL power and target refraction
timeFrame: Operative (day of Surgery)
measure: Fundus OCT
timeFrame: Pre-OP
Locations:
city: Makati City
country: Philippines
facility: Asian Eye Institute
Study officials:
affiliation: Asian Eye Institute
name: Robert Edward Ang, MD
role: PRINCIPAL_INVESTIGATOR
References: