Accuracy of IOLMASTER 700 Total Keratometry (TK)

February 18, 2026 updated by: Advanced Vision Care

Accuracy of IOLMASTER 700 Total Keratometry (TK) in Patients Undergoing Post-Laser Vision Correction Cataract Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Empire Eye & Laser Center
      • Los Angeles, California, United States, 90067
        • Advanced Vision Care
      • Torrance, California, United States, 90505
        • Wolstan & Goldberg Eye Associates
    • Maryland
      • Bowie, Maryland, United States, 20716
        • Solomon Eye Physicians and Surgeons
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Ophthalmic Partners PC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Storm Eye Institute29425
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia eye consultant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects that have had laser vision correction and cataract surgery (retrospective cohort) or have had laser vision correction surgery and are scheduled for cataract surgery (prospective cohort).

Description

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 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).

  3. Best corrected distance visual acuity (BCDVA) potential of 20/30 or better (as measured by Retinal Acuity Meter (RAM) or Potential Acuity Meter (PAM).
  4. Patients who have a manifest refraction that is myopic or hyperopic after previous LVC.
  5. 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.
  6. Signed and received a copy of the signed written informed consent (pertain to the prospective subjects only).
  7. For prospective patients, willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.

Exclusion Criteria:

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

    1. Corneal pathology - Epithelial Basement Membrane Dystrophy (EMBD), Irregular Astigmatism, Decentered LASIK/PRK, Radial Keratotomy (RK), Fuchs Dystrophy
    2. Retinal pathology - Visually significant Epiretinal Membrane (ERM) with loss of foveal contour, Large/ Medium Drusen, Cystoid Macular Edema (CME), History of Retinal Detachment
    3. Optic neuropathy
    4. Advanced glaucoma
    5. Amblyopia
    6. Strabismus
    7. Relative Afferent Pupillary Defect (RAPD) indicating an optic neuropathy.
  2. 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.
  3. Patient who had to undergo A-scan measurement to retrieve Axial Length (AL) values.
  4. 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).
  5. Patients in whom the study eye experiences any intraoperative surgical complications or complex cataract surgeries (vitrectomy, corneal suturing).
  6. Patients with previous LVC where one eye was treated for myopia and the other eye was treated for hyperopia.
  7. Patient is participating in another study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective
Device: IOLMASTER 700 TK
4 different intraocular lens (IOL) calculation methods (Haigis TK, ASCRS calculator, Barrett True K Classic K, Barrett True K TK) will be performed using the preoperative biometry and post operative refraction data.
Prospective
Device: IOLMASTER 700 TK
4 different intraocular lens (IOL) calculation methods (Haigis TK, ASCRS calculator, Barrett True K Classic K, Barrett True K TK) will be performed using the preoperative biometry and post operative refraction data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Keratometry Accuracy Assessment
Time Frame: 4 Weeks
Subjects utilizing Total Keratometry within (+/- 0.50 D, +/- 0.75 D, +/- 1.00 D) compared to the proportion of subjects utilizing traditional keratometry readings.
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Vision Care

Collaborators

Clinical Research Consultants, Inc.

Investigators

  • Principal Investigator: Nicole Fram, MD, Advanced Vision Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2022

Primary Completion (Actual)

January 27, 2024

Study Completion (Actual)

January 27, 2024

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVC-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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