The objective of this investigation is to describe visual outcomes and assess the safety at 12 months (330 - 420 days) post bilateral implantation of the AcrySof® IQ PanOptix* Presbyopia correcting IOL Model TFNT00.
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the visual outcomes and safety over a period of 12 months (330 - 420
days)
Secondary outcome
Not applicable
Background summary
Presbyopia is a condition in which the eye gradually loses the ability to focus
on near objects, or accommodate. This condition affects almost all people aged
sixty and beyond. The modern day quest for perfect vision after cataract
surgery includes restoration of this accommodative
capability. Several approaches for treating presbyopia through the design of
IOLs exist in practice, including the use of multifocal IOLs. Multifocal IOLs
offer the cataract patient an opportunity to have the effects of presbyopia
corrected after cataract surgery by providing multiple focal points. The
majority of commercially available multifocal IOLs provide two optical zones
for distance and near vision. The ACRYSOF IQ PanOptix Presbyopia IOL Model
TFNT00 uses similar technology of commercially available multifocal IOLs to
create an additional focal point for intermediate vision.
Study objective
The objective of this investigation is to describe visual outcomes and assess
the safety at 12 months (330 - 420 days) post bilateral implantation of the
AcrySof® IQ PanOptix* Presbyopia correcting IOL Model TFNT00.
Study design
This is a prospective, multicenter study requiring implantation of the
AcrySof® IQ PanOptix* Presbyopia correcting IOL Model TFNT00 in both eyes. The
study will take about 12 months (330 - 420 days).
Intervention
Eye surgery with removal of the original lens and replacement by an
ibntraocular lens.
Study burden and risks
The patients will be asked to visit the hospital 10 times in 12 months. Each
visit will take in between 20 minutes and 3 hours. Exceptionally a visit can
take longer. None of the tests are experimental. There some risks associated
with routine cataract surgery. These risks include bleeding, infection,
inflammation, detachment of the retina, increased eye pressure, and swelling
under the retina. There is a small chance that vision could actually be made
worse by the surgical procedure. If the lens is not in the correct position,
the vision may also be affected and the normal flow of fluid within the eye may
be blocked. The patient may require additional surgery to treat these side
effects and improve surgery results.
Multifocal lenses are significantly different than standard monofocal lenses.
Although the multifocal lens is designed to provide near and intermediate
vision in addition to distance vision, it is possible that the patient's near
vision may not be asclear or as sharp in low light as with a monofocal lens
implant when used with glasses. Even with a ultifocal lens, the patient may
also need to wear reading glasses to see up close under dim lighting conditions.
The potential vision problems listed above may trouble the patient enough to
require removal of the intraocular lens that was implanted. If there is a
reduction in the vision (near or far) or if the patient has visual symptoms
that cannot be tolerated, the doctor may need to perform a second surgery to
reposition, remove or replace the intraocular lens.
During the study, at different visits, the patient may have eye drops used for
pupil dilation which may cause temporary sensitivityto light and blurred
vision. Sunglasses should be worn in bright light. Driving a car or performing
any hazardous activity should not be done until the effects of the medication
are gone and normal vision returns.
Eye pressure may be tested during the study. The eye pressure test involves the
placement of eye drops containing a small amount of a numbing drop into the
eye. It is important that the patient does not rub your eyes for at least 15
minutes after the drops are put into the eye, since small particles or dust in
the eye might scratch the cornea and the numbing drop would make the patient
temporarily unable to feel the pain. Minor scratching of the corneal surface
may rarely occur when the pressure in the eye is measured.
I addition there is always the risk that uncommon or previously unknown side
effects may occur.
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Listed location countries
Age
Inclusion criteria
1. Adults, 22 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;;2. Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;;3. Calculated lens power within the available range;;4. Preoperative BCDVA worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in both eyes;;5. Potential postoperative BCDVA of 0.20 logMAR or better in both eyes based on Investigator expert medical opinion. (NOTE: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial);;6. Preoperative regular corneal astigmatism of < 1.00 D, in both eyes;;7. Clear intraocular media other than cataract in both eyes.
Exclusion criteria
Prior operation;1. Clinically significant corneal abnormalities including corneal dystrophy (eg, epithelial,stromal, or endothelial dystrophy), inflammation or edema per the Investigator*s expert medical opinion.
Note: conditions including, but not limited to: keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or keratectasia should be excluded;;2. Previous corneal transplant;;3. Ocular trauma, previous refractive surgery or refractive surgery procedures throughout the entire duration of the subjects* participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);;4. History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that the Investigator judges could confound outcomes (NOTE: Including but not limited to background diabetic retinopathy, diabetic macular edema or proliferative diabetic retinopathy, macular degeneration);;5. Ambylopia;;6. Rubella, congenital, traumatic, or complicated cataracts;;7. Extremely shallow anterior chamber (* 2.5 mm), not due to swollen cataract;;8. Any current anterior or posterior segment inflammation of any etiology, and /or history of any disease producing an intraocular inflammatory reaction;;9. Iris neovascularization;;10. Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;;11. Optic nerve atrophy;;12. Subjects with diagnosed degenerative eye disorders;;13. Known color vision deficiencies;;14. Pregnancy or lactation;;15. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation;;16. Subjects who may reasonably be expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);;17. Situations where the need for a large capsulotomy can be anticipated (eg, diabetics, retinal detachment in the fellow eye, peripheral retinal pathology, etc.);;18. Subjects who are expected to require retinal laser treatment.;During Surgery;1. Any other additional procedures during the phacoemulsification and IOL implant due to intraoperative complications that require further intervention (including but not limited to posterior capture rupture, vitreous loss, zonular dehiscence that may make the IOL implant less stable, etc.);;2. Zonular or Capsule rupture;;3. Excessive iris mobility;;4. Mechanical or surgical manipulation required to enlarge the pupil prior to or at IOL implantation (pupil size must be at least 4.5 mm or larger just prior to implantation);;5. Significant anterior chamber bleeding;;6. Uncontrolled intraocular pressure;;7. Unrecognized (pre-existing but discovered during surgery ocular conditions or complications in which the IOL stability could be compromised, including zonular weakness;;8. Any incision site other than temporal;;9. Bag-sulcus, sulcus-sulcus or unknown placement of the haptics;;10. Capsulorhexis tears or any areas of *can-opener* capsulotomy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02529488 |
| CCMO | NL55425.068.15 |