Clinical trial NCT03306355: Comparison of Clinical Outcomes on Trifocal IOLs FineVision POD F GF and FineVision POD F in Asian Eyes
Official title: Clinical Study to Compare Clinical Outcomes of IOLs FineVision POD F GF (Hydrophobic) and FineVision POD F (Hydrophilic) After Bilateral Implantation in Asian Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Presbyopia
Keywords: Intraocular Lens
trifocal
hydrophobic
hydrophilic
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-11
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs with different material (hydrophobic and hydrophilic) from the same manufacturer. Implantation of the IOLs is bilaterally.

Detailed description: This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision POD F (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD F GF 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 the material (hydrophobic and hydrophilic). 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 12 study visits (1 preoperative, 2 operative and 9 postoperative) over a period of 36 months. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 3 months follow up visit and secondary endpoint data will be collected at the 3, 12, 24 and 36 months follow up visits. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Eligibility criteria: Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Unrealistic expectation
* Age of patient \<45 years
* Irregular astigmatism
* Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* Age-related Macular Degeneration (AMD) suspicious eyes (determined by OCT)
* Complicated surgery

Primary outcomes:
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Manifested refraction
timeFrame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Uncorrected Distance Visual Acuity (UDVA) - monocular
timeFrame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Uncorrected Distance Visual Acuity (UDVA) - binocular
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Corrected Distance Visual Acuity (CDVA) - monocular
timeFrame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Corrected Distance Visual Acuity (CDVA) - binocular
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular
timeFrame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular
timeFrame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
timeFrame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Uncorrected Near Visual Acuity at 35cm (UNVA)
timeFrame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Uncorrected Near Visual Acuity at 35cm (UNVA)
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Contrast Sensitivity
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Aberrometry
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: AcuTarget diagnostic device
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Visual Functioning Questionnaire - 25 (VFQ-25)
timeFrame: 3 months postoperative, 12 months postoperative.
measure: Defocus Curve
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - Corneal Status
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - Fundus
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - Signs of inflammation
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - Pupillary block
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - Retinal detachment
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - Status of anterior and posterior capsule
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - IOL decentration
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - IOL tilt
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - IOL discoloration
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Slitlamp examination - IOL opacity
timeFrame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Other outcomes:
measure: Intraocular pressure (IOP) measurement
timeFrame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
measure: Keratometry
timeFrame: Pre-OP
measure: Biometry
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: