Accuracy of IOLMASTER 700 Total Keratometry (TK)

NCT05254587 | Completed FDA Device

• 1 other identifier: AVC-005
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 7

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.

Conditions

Cataract; Myopia; Hyperopia

Keywords

Laser Vision Correction; Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Retrospective

Device: IOLMASTER 700 TK

Prospective

Device: IOLMASTER 700 TK

Interventions

IOLMASTER 700 TK DEVICE

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; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• 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).
• 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.

You may not qualify if:

• 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.
• 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.
• Patient who had to undergo A-scan measurement to retrieve Axial Length (AL) values.
• 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).
• Patients in whom the study eye experiences any intraoperative surgical complications or complex cataract surgeries (vitrectomy, corneal suturing).
• Patients with previous LVC where one eye was treated for myopia and the other eye was treated for hyperopia.
• Patient is participating in another study.

Sponsors & Collaborators

• Advanced Vision Care: lead
• Clinical Research Consultants, Inc.: collaborator

Study Sites (7)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Advanced Vision Care

Los Angeles, California, 90067, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Solomon Eye Physicians and Surgeons

Bowie, Maryland, 20716, United States

Location

Ophthalmic Partners PC

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

MUSC Storm Eye Institute29425

Charleston, South Carolina, 29425, United States

Location

Virginia eye consultant

Norfolk, Virginia, 23502, United States

Location

Related Publications (17)

• Moshirfar M, Wagner WD, Linn SH, Skanchy DF, Brown TW, Gomez AT, Goldberg JL, Ronquillo YC, Hoopes PC Jr. Astigmatic correction with implantation of a light adjustable vs monofocal lens: a single site analysis of a randomized controlled trial. Int J Ophthalmol. 2019 Jul 18;12(7):1101-1107. doi: 10.18240/ijo.2019.07.08. eCollection 2019.

  PMID: 31341799 BACKGROUND

• Aristodemou P, Knox Cartwright NE, Sparrow JM, Johnston RL. Formula choice: Hoffer Q, Holladay 1, or SRK/T and refractive outcomes in 8108 eyes after cataract surgery with biometry by partial coherence interferometry. J Cataract Refract Surg. 2011 Jan;37(1):63-71. doi: 10.1016/j.jcrs.2010.07.032.

  PMID: 21183100 BACKGROUND

• Kane JX, Van Heerden A, Atik A, Petsoglou C. Accuracy of 3 new methods for intraocular lens power selection. J Cataract Refract Surg. 2017 Mar;43(3):333-339. doi: 10.1016/j.jcrs.2016.12.021.

  PMID: 28410714 BACKGROUND

• Anter AM, Bleeker AR, Shammas HJ, Suraneni S, Kingrey B, Murphy DA, Leal S, Ghalibafan S, Tonk RS, Cooke DL, Riaz KM. Comparison of Legacy and New No-History IOL Power Calculation Formulas in Postmyopic Laser Vision Correction Eyes. Am J Ophthalmol. 2024 Aug;264:44-52. doi: 10.1016/j.ajo.2024.03.014. Epub 2024 Mar 20.

  PMID: 38518990 BACKGROUND

• Suraneni S, Bleeker AR, Anter AM, Leal S, Murphy DA, Riaz KM, Cooke DL, Tonk RS. Intraocular Lens Power Calculations in Posthyperopic Laser Vision Correction Eyes: Comparing Legacy and New No-History Formulas. Am J Ophthalmol. 2026 Jan;281:118-125. doi: 10.1016/j.ajo.2025.09.010. Epub 2025 Sep 9.

  PMID: 40935225 BACKGROUND

• Kenny PI, Kozhaya K, Truong P, Wang L, Koch DD, Weikert MP. Performance of IOL calculation formulas that use measured posterior corneal power in eyes following myopic laser vision correction. J Cataract Refract Surg. 2024 Jan 1;50(1):7-11. doi: 10.1097/j.jcrs.0000000000001300.

  PMID: 37702522 BACKGROUND

• Yeo TK, Heng WJ, Pek D, Wong J, Fam HB. Accuracy of intraocular lens formulas using total keratometry in eyes with previous myopic laser refractive surgery. Eye (Lond). 2021 Jun;35(6):1705-1711. doi: 10.1038/s41433-020-01159-5. Epub 2020 Aug 31.

  PMID: 32868880 BACKGROUND

• Lawless M, Jiang JY, Hodge C, Sutton G, Roberts TV, Barrett G. Total keratometry in intraocular lens power calculations in eyes with previous laser refractive surgery. Clin Exp Ophthalmol. 2020 Aug;48(6):749-756. doi: 10.1111/ceo.13760. Epub 2020 Apr 27.

  PMID: 32279436 BACKGROUND

• Abulafia A, Hill WE, Koch DD, Wang L, Barrett GD. Accuracy of the Barrett True-K formula for intraocular lens power prediction after laser in situ keratomileusis or photorefractive keratectomy for myopia. J Cataract Refract Surg. 2016 Mar;42(3):363-9. doi: 10.1016/j.jcrs.2015.11.039. Epub 2016 Mar 19.

  PMID: 27006324 BACKGROUND

• Masket S, Masket SE. Simple regression formula for intraocular lens power adjustment in eyes requiring cataract surgery after excimer laser photoablation. J Cataract Refract Surg. 2006 Mar;32(3):430-4. doi: 10.1016/j.jcrs.2005.12.106.

  PMID: 16631051 BACKGROUND

• Gale RP, Saldana M, Johnston RL, Zuberbuhler B, McKibbin M. Benchmark standards for refractive outcomes after NHS cataract surgery. Eye (Lond). 2009 Jan;23(1):149-52. doi: 10.1038/sj.eye.6702954. Epub 2007 Aug 24.

  PMID: 17721503 BACKGROUND

• Fram NR, Masket S, Wang L. Comparison of Intraoperative Aberrometry, OCT-Based IOL Formula, Haigis-L, and Masket Formulae for IOL Power Calculation after Laser Vision Correction. Ophthalmology. 2015 Jun;122(6):1096-101. doi: 10.1016/j.ophtha.2015.01.027. Epub 2015 Mar 10.

  PMID: 25766733 BACKGROUND

• Ladas JG, Stark WJ. Calculating IOL power after refractive surgery. J Cataract Refract Surg. 2004 Dec;30(12):2458; author reply 2458-9. doi: 10.1016/j.jcrs.2004.10.013. No abstract available.

  PMID: 15617892 BACKGROUND

• Gimbel HV, Sun R. Accuracy and predictability of intraocular lens power calculation after laser in situ keratomileusis. J Cataract Refract Surg. 2001 Apr;27(4):571-6. doi: 10.1016/s0886-3350(00)00795-1.

  PMID: 11311626 BACKGROUND

• Wang L, Tang M, Huang D, Weikert MP, Koch DD. Comparison of Newer Intraocular Lens Power Calculation Methods for Eyes after Corneal Refractive Surgery. Ophthalmology. 2015 Dec;122(12):2443-9. doi: 10.1016/j.ophtha.2015.08.037. Epub 2015 Oct 14.

  PMID: 26459996 BACKGROUND

• Joffe SN. The 25th Anniversary of Laser Vision Correction in the United States. Clin Ophthalmol. 2021 Mar 17;15:1163-1172. doi: 10.2147/OPTH.S299752. eCollection 2021.

  PMID: 33762815 BACKGROUND

• Rossi T, Romano MR, Iannetta D, Romano V, Gualdi L, D'Agostino I, Ripandelli G. Cataract surgery practice patterns worldwide: a survey. BMJ Open Ophthalmol. 2021 Jan 13;6(1):e000464. doi: 10.1136/bmjophth-2020-000464. eCollection 2021.

  PMID: 33501377 BACKGROUND

MeSH Terms

Conditions

Myopia; Hyperopia; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Study Officials

• Nicole Fram, MD

  Advanced Vision Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: February 8, 2022
• Primary Completion: January 27, 2024
• Study Completion: January 27, 2024
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)