Phase
Condition
Vision Loss
Eye Disorders/infections
Eye Disease
Treatment
IOLMASTER 700 TK
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults, 18 years of age or older at the time of cataract surgery.
Patient has had LVC and IOL cataract surgery within 3 years or is scheduled toundergo IOL cataract surgery performed for the treatment of visually significantcataracts. Note: The only IOLs permitted for use in this study are Monofocal (ZCBOO, LI61AO,SN60WF, SA60WF, MX60E) and Toric Lenses (Tecnis 2 ZCU, ZCT, SN6ATx, SA6ATx, MX60ET).
Best corrected distance visual acuity (BCDVA) potential of 20/30 or better (asmeasured by Retinal Acuity Meter (RAM) or Potential Acuity Meter (PAM).
Patients who have a manifest refraction that is myopic or hyperopic after previousLVC.
Patients that have biometric measurements (including Axial Length) for the IOLcataract surgery that were performed preoperatively with the IOLMaster700, includingBarrett True K /TK.
Signed and received a copy of the signed written informed consent (pertain to theprospective subjects only).
For prospective patients, willingness and ability to comply with schedule forfollow-up visits and postoperative evaluations.
Exclusion
Exclusion Criteria:
Patients with a history of any of the following:
Corneal pathology - Epithelial Basement Membrane Dystrophy (EMBD), IrregularAstigmatism, Decentered LASIK/PRK, Radial Keratotomy (RK), Fuchs Dystrophy
Retinal pathology - Visually significant Epiretinal Membrane (ERM) with loss offoveal contour, Large/ Medium Drusen, Cystoid Macular Edema (CME), History ofRetinal Detachment
Optic neuropathy
Advanced glaucoma
Amblyopia
Strabismus
Relative Afferent Pupillary Defect (RAPD) indicating an optic neuropathy.
Patients with a previous history of small incision lenticule extraction (SMILE)surgery and/or glaucoma filtering procedure (defined as tubes or trabeculectomy)other than photorefractive keratectomy (PRK) or LASIK.
Patient who had to undergo A-scan measurement to retrieve Axial Length (AL) values.
Patient has had LVC and IOL cataract surgery within 3 years or is scheduled toundergo IOL cataract surgery performed for the treatment of visually significantcataracts with the presence or intention of implanting a multifocal, extended depthof focus, accommodating and light adjustable lens (such as, but not limited to, TFAT / TFNT; DAT / DFT; ICB00/DIB/DIU/DAT; ZXT; DFW; SN6AD1; AT-50; RxSIGHT).
Patients in whom the study eye experiences any intraoperative surgical complicationsor complex cataract surgeries (vitrectomy, corneal suturing).
Patients with previous LVC where one eye was treated for myopia and the other eyewas treated for hyperopia.
Patient is participating in another study.
Study Design
Study Description
Connect with a study center
Empire Eye & Laser Center
Bakersfield, California 93309
United StatesSite Not Available
Advanced Vision Care
Los Angeles, California 90067
United StatesSite Not Available
Wolstan & Goldberg Eye Associates
Torrance, California 90505
United StatesSite Not Available
Solomon Eye Physicians and Surgeons
Bowie, Maryland 20716
United StatesSite Not Available
Ophthalmic Partners PC
Bala-Cynwyd, Pennsylvania 19004
United StatesSite Not Available
MUSC Storm Eye Institute29425
Charleston, South Carolina 29425
United StatesSite Not Available
Virginia eye consultant
Norfolk, Virginia 23502
United StatesSite Not Available
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