CompletedNot Applicable

Accuracy of IOLMASTER 700 Total Keratometry (TK)

United States155 participantsStarted 2022-02-08

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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 to undergo IOL cataract surgery performed for the treatment of visually significant cataracts.
✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Total Keratometry Accuracy Assessment

Timeframe: 4 Weeks

Trial details

NCT IDNCT05254587

SponsorAdvanced Vision Care

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-27

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