Accuracy of IOLMASTER 700 Total Keratometry (TK)

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: Recruiting
• Conditions: Cataract; Myopia; Hyperopia
• Intervention / Treatment: Device: IOLMASTER 700 TK

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 (Estimated): 200

Contacts and Locations

• Study Contact: Name: Orly Shiler; Phone Number: 310-229-1220; Email: orlyjr@inorbit.com

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Recruiting
      • Empire Eye & Laser Center
      • Principal Investigator: Daniel Chang, M.D.
      • Contact: Jacque Whinery; Phone Number: 661-325-3937; Email: jwhinery@empireeyeandlaser.com
    • Los Angeles, California, United States, 90067
      • Recruiting
      • Advanced Vision Care
      • Principal Investigator: Nicole Fram, MD
      • Contact: Orly Shiler; Phone Number: 310-229-1220; Email: orlyjr@inorbit.com
    • Torrance, California, United States, 90505
      • Recruiting
      • Wolstan & Goldberg Eye Associates
      • Contact: Cynthia Hernandez Montes; Phone Number: 310-602-5640; Email: cynthia@wgeye.com
      • Principal Investigator: Damien Goldberg, MD
  • Maryland
    • Bowie, Maryland, United States, 20716
      • Completed
      • Solomon Eye Physicians and Surgeons
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Recruiting
      • Ophthalmic Partners PC
      • Contact: Gwen Toti; Phone Number: 484-434-2706; Email: gtoti@oppdoctors.com
      • Principal Investigator: Brandon Ayres, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • MUSC Storm Eye Institute29425
      • Contact: Nikki Weas; Phone Number: 843-792-2338; Email: weasn@musc.edu
      • Principal Investigator: Karolinne Rocha, MD, PhD
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia eye consultant
      • Principal Investigator: Elizabeth Yeu, M.D.
      • Contact: Joshua Hammond; Phone Number: 757-622-2200; Email: joshuahammond@eyecare-partners.com

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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

• Sponsor: Advanced Vision Care
• Collaborators: Clinical Research Consultants, Inc.
• Investigators: Principal Investigator: Nicole Fram, MD, Advanced Vision Care

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 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): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cataract Surgery; Laser Vision Correction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Hyperopia
• 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