Accuracy of IOLMASTER 700 Total Keratometry (TK)

Completed

Conditions studied: Myopia, Hyperopia, Cataract

In brief

This is a multicenter study to compare the accuracy of IOL calculations in post-laser vision corrected eyes that are about to undergo or have undergone cataract surgery.

Key facts

Study ID

NCT05254587

Run by

Advanced Vision Care

People needed

155

Starts

2022-02-08

Expected to finish

2024-01-27

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 to undergo IOL cataract surgery performed for the treatment of visually significant cataracts.
• 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 (as measured by Retinal Acuity Meter (RAM) or Potential Acuity Meter (PAM).
• Patients who have a manifest refraction that is myopic or hyperopic after previous LVC.
• Patients that have biometric measurements (including Axial Length) for the IOL cataract surgery that were performed preoperatively with the IOLMaster700, including Barrett True K /TK.
• Signed and received a copy of the signed written informed consent (pertain to the prospective subjects only).
• For prospective patients, willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.

You may not qualify if…

• Patients with a history of any of the following:
• Corneal pathology - Epithelial Basement Membrane Dystrophy (EMBD), Irregular Astigmatism, Decentered LASIK/PRK, Radial Keratotomy (RK), Fuchs Dystrophy
• Retinal pathology - Visually significant Epiretinal Membrane (ERM) with loss of foveal contour, Large/ Medium Drusen, Cystoid Macular Edema (CME), History of Retinal 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 to undergo IOL cataract surgery performed for the treatment of visually significant cataracts with the presence or intention of implanting a multifocal, extended depth of 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 complications or complex cataract surgeries (vitrectomy, corneal suturing).
• Patients with previous LVC where one eye was treated for myopia and the other eye was treated for hyperopia.
• Patient is participating in another study.

Where it is running

• Empire Eye & Laser Center — Bakersfield, California, United States
• Advanced Vision Care — Los Angeles, California, United States
• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• Solomon Eye Physicians and Surgeons — Bowie, Maryland, United States
• Ophthalmic Partners PC — Bala-Cynwyd, Pennsylvania, United States
• MUSC Storm Eye Institute29425 — Charleston, South Carolina, United States
• Virginia eye consultant — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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