CataractPHY1706NCT03306355

Comparison of Clinical Outcomes on Trifocal IOLs FineVision POD F GF and FineVision POD F in Asian Eyes

A study testing IOL implantation experimental and IOL implantation active comparator in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for: Cataract, Lens Opacities, Presbyopia
What is being tested?: IOL implantation experimental and IOL implantation active comparator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 sitePhilippines
Study dates: 4 Dec 2017to 10 Feb 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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…)

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Philippines1 site

Asian Eye Institute
Makati City, 1200

Other trials in Philippines

About this study

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

Read the 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.

Conditions: Cataract, Lens Opacities, Presbyopia
Being tested: IOL implantation experimental, IOL implantation active comparator
Keywords: Intraocular Lens, trifocal, hydrophobic, hydrophilic
Medical subject headings: Cataract, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IOL implantation experimentalDevice
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
IOL implantation active comparatorDevice
Implantation of trifocal IOL POD F consisting of hydrophilic material

Study groups in NCT03306355
Study group	Role	What they receive
IOL implantation experimental	Experimental	hydrophobic, trifocal intraocular lens POD F GF Receives: Device: IOL implantation experimental
IOL implantation active comparator	Active comparator	hydrophilic, trifocal intraocular lens POD F Receives: Device: IOL implantation active comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
Measured: 3 months postoperative

Secondary outcomes (28)

Manifested refraction
The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
Measured: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Distance Visual Acuity (UDVA) - monocular
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly.
Measured: 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Distance Visual Acuity (UDVA) - binocular
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly.
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Corrected Distance Visual Acuity (CDVA) - monocular
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly.
Measured: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Corrected Distance Visual Acuity (CDVA) - binocular
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done binocularly.
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly.
Measured: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly.
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular
UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly.
Measured: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular
UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly.
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly.
Measured: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly.
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Near Visual Acuity at 35cm (UNVA)
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly.
Measured: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Near Visual Acuity at 35cm (UNVA)
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly.
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Aberrometry
Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
AcuTarget diagnostic device
Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Visual Functioning Questionnaire - 25 (VFQ-25)
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified Visual Functioning Questionnaire - 25 (VFQ-25) will be used. The maximum score for each questionaire is 100.
Measured: 3 months postoperative, 12 months postoperative.
Defocus Curve
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. This examination is performed monocularly and binocularly.
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Corneal Status
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Corneal Status
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Fundus
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Fundus
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Signs of inflammation
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Signs of inflammation
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Pupillary block
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Pupillary block
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Retinal detachment
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Retinal detachment
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Status of anterior and posterior capsule
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- Status of anterior and posterior capsule
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL decentration
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- IOL decentration
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL tilt
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- IOL tilt
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL discoloration
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- IOL discoloration
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL opacity
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:
- IOL opacity
Measured: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 201710 Feb 2022

First posted11 Oct 2017
Study start4 Dec 2017
Primary completion24 Jan 2019
Study completion10 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03306355
Sponsor's protocol ID: PHY 1706
Acronym: PHY1706
Status last verified: Jul 2023
First submitted: 28 Sep 2017
Last updated: 27 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03306355
Acronym / sponsor ID: PHY1706 / PHY 1706
Conditions: Cataract, Lens Opacities, Presbyopia
Keywords: Intraocular Lens, trifocal, hydrophobic, hydrophilic
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
Study start: 4 Dec 2017 (actual)
Primary completion: 24 Jan 2019 (actual)
Study completion: 10 Feb 2022 (actual)
First posted: 11 Oct 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IOL implantation experimental	Experimental	Device: IOL implantation experimentalhydrophobic, trifocal intraocular lens POD F GF
IOL implantation active comparator	Active comparator	Device: IOL implantation active comparatorhydrophilic, trifocal intraocular lens POD F

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IOL implantation experimentalImplantation of trifocal IOL POD F GF consisting of hydrophobic material	Device	IOL implantation experimental
IOL implantation active comparatorImplantation of trifocal IOL POD F consisting of hydrophilic material	Device	IOL implantation active comparator

Primary outcome

Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
Time frame: 3 months postoperative
No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014

28 secondary outcomes

Manifested refraction
Time frame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Distance Visual Acuity (UDVA) - monocular
Time frame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Distance Visual Acuity (UDVA) - binocular
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Corrected Distance Visual Acuity (CDVA) - monocular
Time frame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Corrected Distance Visual Acuity (CDVA) - binocular
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular
Time frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular
Time frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
Time frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Near Visual Acuity at 35cm (UNVA)
Time frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Near Visual Acuity at 35cm (UNVA)
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Contrast Sensitivity
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Aberrometry
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
AcuTarget diagnostic device
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Visual Functioning Questionnaire - 25 (VFQ-25)
Time frame: 3 months postoperative, 12 months postoperative.
Defocus Curve
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Corneal Status
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Fundus
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Signs of inflammation
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Pupillary block
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Retinal detachment
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Status of anterior and posterior capsule
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL decentration
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL tilt
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL discoloration
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL opacity
Time frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Edward Ang, MD principal investigator

Asian Eye Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IOL implantation experimental and IOL implantation active comparator in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. (time frame: 3 months postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03306355.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.