The objective of this study is to evaluate the safety of the AcuFocusTM ACI 7000PDT corneal inlay implanted intra-stromally in emmetropic presbyopes and the effectiveness of the inlay for improvement of near vision.
ID
Source
Brief title
Condition
- Ocular structural change, deposit and degeneration NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Improvement in uncorrected near visual acuity (40cm/16in.) at 12 months. 75%
of eyes should achieve uncorrected near
visual acuity of 20/40 or better.
- Subjective improvement in near vision as measured by subject satisfaction
questionnaire.
Secondary outcome
- Preservation of best-corrected visual acuity
Fewer than 5% of eyes should have a persistent loss of two lines or more of
best-corrected distance visual acuity and less than 1% of eyes with
preoperative best spectacle corrected distance visual acuity of 20/20 should
have bestcorrected distance visual acuity worse than 20/40 at 12
months.
- Mean extent of induced manifest refractive astigmatism
Fewer than 5% of eyes should have postoperative manifest refractive astigmatism
that increases from baseline by greater than 2.00 D at the postoperative
interval at 12 months.
- Results of slit lamp examination
Fewer than 1% of eyes should have clinically significant haze on slit lamp
examination, defined as a decrease in BCDVA of more than two lines not due to
irregular astigmatism, at 12 months.
- Cumulative incidence of adverse events
Adverse events related to the device should occur in no more than 5% of eyes
and any single adverse event related to the device should occur in no more than
1% of eyes.
Background summary
The patient is invited to take part in a research study because the patient has
prebyopia. This means the patient has difficulty reading or seeing near objects
without glasses or contact lenses.
Study objective
The objective of this study is to evaluate the safety of the AcuFocusTM ACI
7000PDT corneal inlay implanted intra-stromally in emmetropic presbyopes and
the effectiveness of the inlay for improvement of near vision.
Study design
This will be a prospective multicenter clinical trial in which a maximum of 150
consecutive eyes of 150 patients will be implanted with the ACI 7000PDT and
followed with postoperative visits over a 12 month period at a maximum of 12
clinical sites. Each clinical site should contribute a minimum of 15 subjects
to the study population, but no more than 25% of the total subjects in the
study.
Subjects will be screened for eligibility, and informed consent will be
obtained from those who meet the screening criteria and are interested in
participation in the study. Eligible subjects will be examined preoperatively
to obtain a medical history and to establish a baseline for their ocular
condition. Qualified subjects who provide written consent will undergo
intrastromal placement of an ACI.
The surgical procedure will be performed by creating a lamellar dissection with
a femtosecond laser and placing the ACI under the dissection. The ACI will be
implanted in the non-dominant eye unless psychophysical testing determines that
the inlay should be implanted in the dominant eye.
Postoperatively, subjects will undergo complete ophthalmic examination at
regular intervals to evaluate safety and effectiveness of the ACI in improving
near vision.
Study burden and risks
-
32 Discovery, Suite 200
Irvine, CA 92618
US
32 Discovery, Suite 200
Irvine, CA 92618
US
Listed location countries
Age
Inclusion criteria
1. Subjects must sign and be given a copy of the written Informed Consent form.
2. Subjects must be emmetropes needing a magnitude of +1.00D to +2.50D of reading
add.
3. Subjects must have uncorrected near visual acuity worse than 20/40 and better
than 20/100 in the eye to be implanted.
4. Subjects must have distance visual acuity correctable to at least 20/20 in both eyes.
5. Subjects must have a preoperative spherical equivalent of plano defined as +0.50D to -0.75D with no more than 0.75D of refractive cylinder as determined by cycloplegic refraction in the eye to be implanted.
6. Subjects must have a stable refraction twelve months prior to ACI implantation: i.e.
MRSE within 0.50D over prior twelve months as determined by subject history.
7. Subjects who are soft contact lens wearers must discontinue their contact lenses for
at least one week prior to ACI pre-operative examination.
8. Subjects must have a minimum central corneal thickness of >= 500 microns in the eye
to be implanted.
9. Subjects must have a corneal power of >= 41.00D and <= 47.00D in all meridians in
the eye to be implanted.
10. Subjects must be >= 45 years and <= 60 years of age at the time of subject eligibility
visit.
11. Subjects must have an endothelial cell count >= 2000 cells/mm2 in the eye to be
implanted.
12. Subjects must be willing and able to return for scheduled follow-up examinations for
12 months after surgery.
13. Subjects must demonstrate tolerance to monovision blur in the eye to be implanted
as determined by loose lens blur tolerance or monovision contact lens trial.
Exclusion criteria
1. Subjects with a difference of >1.00D between the spherical equivalent manifest
refraction and the spherical equivalent cycloplegic refraction.
2. Subjects with anterior segment pathology, including cataracts, in the eye to be
implanted.
3. Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease, or any
corneal abnormality (including endothelial dystrophy, guttata, recurrent corneal
erosion, etc.) in the eye to be implanted.
4. Subjects with ophthalmoscopic or topographic signs of keratoconus (or keratoconus
suspect) or keratoectasia in the eye to be implanted.
5. Subjects with dry eye as determined by objective testing; anesthetized Schirmer*s
test result <10 mm or a tear break-up time (TBUT) less than 10 seconds are
excluded.
6. Subjects taking chronic systemic medications known to exacerbate or induce
moderate to severe dry eye in so far as measures of TBUT and Schirmers are
decreased or borderline per Exclusion Criterion #5. Subjects taking the following
classes of medications should be evaluated: anti-depressants, anti-histamines, betablockers,
phenothiazines, atropine and atropine derivatives, oral contraceptives,
anxiolytics, diuretics, anti-cholinergics, and anti-arrhythmics.
7. Subjects with distorted or unclear corneal mires on topography maps of the eye to be
implanted.
8. Subjects with macular degeneration, retinal detachment, or any other fundus
pathology that would prevent an acceptable visual outcome in the eye to be
implanted.
9. Subjects who have worn RGP or PMMA contact lenses within the last 6 months.
10. Subjects who have undergone previous intraocular or corneal surgery, including
PRK, LASIK, CK, LASEK, and cataract surgery in the eye to be implanted.
11. Subjects with a history of herpes zoster or herpes simplex keratitis.
12. Subjects who have a history of steroid-responsive rise in intraocular pressure,
preoperative IOP > 21 mmHg, glaucoma, ocular hypertension, or are glaucoma
suspects.
13. Subjects with an abnormal threshold visual field.
14. Subjects with a history of diagnosed diabetes, diagnosed autoimmune disease,
connective tissue disease, or clinically significant atopic syndrome.
15. Subjects on chronic systemic corticosteroids or other immunosuppressive therapy
that may affect wound healing, and any immunocompromised subjects.
16. Subjects who are using ophthalmic medication(s) other than artificial tears for
treatment of any ocular pathology including ocular allergy.
17. Subjects using systemic medications with significant ocular side effects.
18. Subjects who are pregnant, lactating, or of child-bearing potential and not practicing
a medically approved method of birth control.
19. Subjects with known sensitivity to planned study concomitant medications.
20. Subjects who are participating in any other ophthalmic drug or device clinical trial
during the time of this clinical investigation.
21. Subjects who require canthotomy to generate a lamellar dissection in the eye to be
implanted.
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 | NCT00850031 |
| CCMO | NL36619.068.11 |