Primary Objective:The primary objective of this study is to demonstrate the long-term (3 years) favorable visual acuity and adverse event outcomes for the Clareon IOL compared to historical SPE rates as reported in EN ISO 11979-7:2014.Secondary…
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The primary analysis set for effectiveness analyses will be the All-Implanted
Analysis Set (AAS). AAS includes all eyes with successful test article
implantation. Additional supportive analyses may be conducted using the
Best-Case Analysis Set (BAS). BAS includes all eyes successfully implanted with
the test article that had no preoperative ocular pathology, no macular
degeneration detected at any time, and no previous surgery for the correction
of refractive errors.
The Safety Analysis Set will include all eyes with attempted implantation with
the test article (successful or aborted after contact with the eye) and will be
used for the safety analyses.
The primary effectiveness objective is to demonstrate that the one-sided exact
95% upper confidence limit for the percentage of subjects with monocular best
corrected distance visual acuity (BCDVA) of 0.3 logMAR or better at 3 years
(Visit 7A) is not worse than SPE rate of 92.5% for AAS (as reported in EN ISO
11979-7:2014). The number and percentages of subjects with BCDVA of 0.3 logMAR
or better at 3 years post-implantation (Visit 7A) will be summarized along with
the corresponding two-sided exact 95% confidence interval.
Three interim analyses summarizing the effectiveness and safety outcomes will
be conducted when all subjects complete visits 4A, 5A, and 6A to support the
study publication plan.
Primary Effectiveness Endpoint
Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 3 years
post-implantation (Visit 7A)
Secondary outcome
Secondary Effectiveness Endpoints
* Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 1 year
post-implantation (Visit 5A)
* Percentage of subjects achieving BCDVA of 0.3 logMAR or better at 2 years
post-implantation (Visit 6A)
* UCDVA at 1 year (Visit 5A) post-implantation
* UCDVA at 2 years (Visit 6A) post-implantation
* UCDVA at 3 years (Visit 7A) post-implantation
Exploratory Effectiveness Endpoints
* Manifest refraction at 1 year post-implantation (Visit 5A)
* Manifest refraction at 2 years post-implantation (Visit 6A)
* Manifest refraction at 3 years post-implantation (Visit 7A)
* Percentage of eyes having Nd:YAG capsulotomy at 1 year (Visit 5A)
* Percentage of eyes having Nd:YAG capsulotomy at 2 years (Visit 6A)
* Percentage of eyes having Nd:YAG capsulotomy at 3 years (Visit 7A)
* Glistenings at 1 month post-implantation (Visit 3A)
* Glistenings at 6 months post-implantation (Visit 4A)
* Glistenings at 1 year post-implantation (Visit 5A)
* Glistenings at 2 years post-implantation (Visit 6A)
* Glistenings at 3 years post-implantation (Visit 7A)
Background summary
The Clareon IOL (Model SY60WF) is a foldable, monofocal IOL intended as an
optical implant for the replacement of the human crystalline lens in the visual
correction of aphakia in adult patients following cataract surgery. The lens
IOL is intended to be placed in the capsular bag in the posterior chamber of
the eye.
The Clareon IOL is a UV-absorbing IOL composed of a high refractive-index
foldable acrylic material. Its design is equivalent in dimensions to the
globally approved ACRYSOF Natural IQ IOL (Model SN60WF). The Clareon IOL is a
monofocal lens of single-piece construction, with a 6.0 mm diameter asymmetric
biconvex posterior optic with an aspheric surface incorporated on the anterior
side of the optic, and an overall length of 13.0 mm. The haptics are
constructed from the same material as the optic with no angulation. The Clareon
IOL is qualified for use with existing Alcon Monarch III-D cartridge and
delivery systems.
The rationale to conduct this post-market study is to provide long-term (3
years) safety and effectiveness data on the Clareon IOL to support the Market
Access requirements including the development of a product value dossier.
Study objective
Primary Objective:
The primary objective of this study is to demonstrate the long-term (3 years)
favorable visual acuity and adverse event outcomes for the Clareon IOL compared
to historical SPE rates as reported in EN ISO 11979-7:2014.
Secondary Objectives:
The secondary objective of this study is to evaluate the refractive outcomes
obtained with up to 3 years follow-up in eyes implanted with the Clareon IOL.
Exploratory Objectives:
* To evaluate the percentage of eyes requiring Nd:YAG capsulotomy with a follow
up period of up to 3-years in eyes implanted with the Clareon IOL
* To assess the formation of glistenings with a follow-up period of up to
3-years in eyes implanted with the Clareon IOL
Study design
This is a prospective, multicenter, single-arm safety and performance clinical
study, requiring no masking. The trial will evaluate the safety and performance
of the Clareon IOL in approximately 200 bilaterally implanted subjects. To
qualify for enrollment into the trial, adult (* 22 years of age) subjects must
require routine, bilateral cataract surgery. Potential subjects will be
screened for enrollment into the trial in accordance with the entry criteria.
Subjects will attend a total of 12 study visits (7 post-implantation) over a
period of approximately 3 years.
Intervention
Eye surgery with removal of the original lens and replacement by an intraocular
lens.
Study burden and risks
In a period of about 3 years the patients will be asked to visit the hospital
12 times (7 after surgery).
None of the assessments or procedures are experimental. However some of them
can cause some inconveniences, such
as:
- Routine cataract surgery can cause bleeding, infection, inflammation,
detachment of the retina, increased eye pressure,
swelling under the retina (in the back of the eye), mild pain or discomfort
after the surgery and damage to other delicate
structures in the eye. There is a small chance that vision could actually be
made worse by the surgical procedure.
- During eye examinations the dilating drops or anesthetic drops may sting when
they are first placed into your eyes.
Dilation of your pupils may
cause some temporary glare and blurring of vision.
-Taking images and photographs of your eyes may cause temporary discomfort from
bright lights and holding your eye
wide open.
Rijksweg 14
Puurs 2870
BE
Rijksweg 14
Puurs 2870
BE
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
2. Able to comprehend and willing to sign an IRB/IEC approved statement of informed consent and complete all required post-implantation visits
3. Planned small incision cataract removal surgery
4. Calculated lens power is within the available range (see Table 11-1 for the available range of lens powers for this study)
5. Subjects for whom postoperative emmetropia is planned (defined as 0.00± 0.50 D spherical equivalent) in both eyes
6. Preoperative BCDVA worse than 0.2 logMAR in at least one eye
Potential post-implantation visual acuity of 0.2 logMAR or better in both eyes based on Investigator expert medical opinion
Exclusion criteria
1. Subjects who may reasonably be expected to require an ocular surgical treatment at any time during the study (other than Nd:YAG capsulotomy)
2. Previous refractive surgery or planned 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)
3. 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.)
4. Amblyopia
5. Previous corneal transplant
6. Extremely shallow anterior chamber (* 2.5 mm), not due to swollen cataract
7. Any recurrent severe anterior or posterior segment inflammation of any etiology, and or history of any disease producing an intraocular inflammatory reaction
8. Rubella, congenital, traumatic, or complicated cataracts
9. Ocular conditions where the need for a large capsulotomy can be anticipated (eg, diabetics, retinal detachment in the fellow eye, peripheral retinal pathology)
10. Iris neovascularization
11. Glaucoma (uncontrolled or controlled with medication)
12. Current or recent use of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha1A adrenoceptor (eg, Flomax (tamsulosin HCL), Hytrin, or Cardura) that in the opinion of the Investigator would potentially require mechanical or surgical manipulation to enlarge the pupil
13. Subjects with diagnosed degenerative eye disorders, such as but not limited to, pseudoexfoliation
14. 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
15. Optic nerve atrophy
16. Subjects who are expected to require retinal laser treatment
17. Subjects with diagnosed congenital ocular disorders, such as but not limited to, aniridia or microphthalmia
18. Pregnancy or lactation current or planned during the course of the study
19. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation
20. Any other additional procedures during the cataract removal and IOL implant due to intraoperative complications that require further intervention (including but not limited to posterior rupture, with vitreous loss, zonular dehiscence that may make the IOL implant less stable
21. Uncontrolled intraocular pressure
22. Significant anterior chamber bleeding
23. Excessive iris mobility
24. Mechanical or surgical intervention required to manipulate the pupil
Note: Pupil size must be 4.5mm or larger just prior to implantation
25. Any capsulorhexis other than continuous curvilinear capsulorhexis (eg, no anterior radial inconsistencies in the capsulorhexis such as anterior capsular tears or any areas of *can-opener* capsulotomy)
26. Unrecognized (pre-existing but discovered during surgery) ocular conditions or complications in which the IOL positions could be less stable, including zonular weakness
27. Zonular or capsular rupture
28. Bag-sulcus, sulcus-sulcus, or unknown placement of the IOL haptics
Note: Intended IOL haptic placement in this study is bag-bag.
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 |
---|---|
CCMO | NL63549.018.17 |