MedPath

A PROSPECTIVE MULTICENTER CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE ACUFOCUS* CORNEAL INLAY ACI 7000PDT IMPLANTED INTRA-STROMALLY FOR MODIFIED MONOVISION IN PRESBYOPIC SUBJECTS

Completed
Conditions
MODIFIED MONOVISION
PRESBYOPIC
10042261
Registration Number
NL-OMON35740
Lead Sponsor
AcuFocus, Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
15
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.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- Improvement in uncorrected near visual acuity (40cm/16in.) at 12 months. 75%<br /><br>of eyes should achieve uncorrected near<br /><br>visual acuity of 20/40 or better.<br /><br>- Subjective improvement in near vision as measured by subject satisfaction<br /><br>questionnaire.</p><br>
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath