Accuracy of IOLMASTER 700 Total Keratometry (TK)

Last updated: June 13, 2024
Sponsor: Advanced Vision Care
Overall Status: Completed

Phase

N/A

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

IOLMASTER 700 TK

Clinical Study ID

NCT05254587
AVC-005
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults, 18 years of age or older at the time of cataract surgery.

  2. 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).

  3. Best corrected distance visual acuity (BCDVA) potential of 20/30 or better (asmeasured by Retinal Acuity Meter (RAM) or Potential Acuity Meter (PAM).

  4. Patients who have a manifest refraction that is myopic or hyperopic after previousLVC.

  5. Patients that have biometric measurements (including Axial Length) for the IOLcataract surgery that were performed preoperatively with the IOLMaster700, includingBarrett True K /TK.

  6. Signed and received a copy of the signed written informed consent (pertain to theprospective subjects only).

  7. For prospective patients, willingness and ability to comply with schedule forfollow-up visits and postoperative evaluations.

Exclusion

Exclusion Criteria:

  1. Patients with a history of any of the following:

  2. Corneal pathology - Epithelial Basement Membrane Dystrophy (EMBD), IrregularAstigmatism, Decentered LASIK/PRK, Radial Keratotomy (RK), Fuchs Dystrophy

  3. Retinal pathology - Visually significant Epiretinal Membrane (ERM) with loss offoveal contour, Large/ Medium Drusen, Cystoid Macular Edema (CME), History ofRetinal Detachment

  4. Optic neuropathy

  5. Advanced glaucoma

  6. Amblyopia

  7. Strabismus

  8. Relative Afferent Pupillary Defect (RAPD) indicating an optic neuropathy.

  9. 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.

  10. Patient who had to undergo A-scan measurement to retrieve Axial Length (AL) values.

  11. 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).

  12. Patients in whom the study eye experiences any intraoperative surgical complicationsor complex cataract surgeries (vitrectomy, corneal suturing).

  13. Patients with previous LVC where one eye was treated for myopia and the other eyewas treated for hyperopia.

  14. Patient is participating in another study.

Study Design

Total Participants: 155
Treatment Group(s): 1
Primary Treatment: IOLMASTER 700 TK
Phase:
Study Start date:
February 08, 2022
Estimated Completion Date:
January 27, 2024

Study Description

This is a multicenter study to compare the accuracy of IOL calculations using 4 different IOL calculation methods (Haigis TK, ASCRS calculator, Barrett True K with classic K, and Barrett True K TK) performed using the preoperative biometry data from post-laser vision correct eyes that are about to undergo or have undergone cataract surgery.

Connect with a study center

  • Empire Eye & Laser Center

    Bakersfield, California 93309
    United States

    Site Not Available

  • Advanced Vision Care

    Los Angeles, California 90067
    United States

    Site Not Available

  • Wolstan & Goldberg Eye Associates

    Torrance, California 90505
    United States

    Site Not Available

  • Solomon Eye Physicians and Surgeons

    Bowie, Maryland 20716
    United States

    Site Not Available

  • Ophthalmic Partners PC

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • MUSC Storm Eye Institute29425

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Virginia eye consultant

    Norfolk, Virginia 23502
    United States

    Site Not Available

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