Accuracy of IOLMASTER 700 Total Keratometry (TK)

Completed

• Conditions: Myopia; Hyperopia; Cataract
• Interventions: Device: IOLMASTER 700 TK

• Registration Number: NCT05254587
• Lead Sponsor: Advanced Vision Care

Brief 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.

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 Timeline

• Study Start: 2022-02-08
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Primary Completion: 2024-01-27
• Study Completion: 2024-01-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective	IOLMASTER 700 TK	-
Prospective	IOLMASTER 700 TK	-

Primary Outcome Measures

Name	Time	Method
Total Keratometry Accuracy Assessment	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.

Trial Locations

Locations (7)

Empire Eye & Laser Center; 🇺🇸 Bakersfield, California, United States

Advanced Vision Care; 🇺🇸 Los Angeles, California, United States

Wolstan & Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

Virginia eye consultant; 🇺🇸 Norfolk, Virginia, United States

Ophthalmic Partners PC; 🇺🇸 Bala-Cynwyd, Pennsylvania, United States

MUSC Storm Eye Institute29425; 🇺🇸 Charleston, South Carolina, United States

Solomon Eye Physicians and Surgeons; 🇺🇸 Bowie, Maryland, United States