ClinicalTrials.gg
CompletedNCT05254587Updated Feb 20, 2026

Accuracy of IOLMASTER 700 Total Keratometry (TK)

An observational study in Myopia, Hyperopia and Cataract, sponsored by Advanced Vision Care. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by Advanced Vision Care · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
155
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Myopia
  • Hyperopia
  • Cataract

Keywords

  • Laser Vision Correction
  • Cataract Surgery
03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's enrollment of 155 is close to the median of 150 across 204 observational studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

This is the only study on the registry with Advanced Vision Care as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
155 participants (actual)
Patient registry
No

Groups and cohorts

  • Retrospective

    Device: IOLMASTER 700 TK

  • Prospective

    Device: IOLMASTER 700 TK

Interventions

  • DeviceIOLMASTER 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.

06

What researchers measure

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.

    Time frame: 4 Weeks

07

Study locations

7 sites
  • Empire Eye & Laser Center
    Bakersfield, California 93309, United States
  • Advanced Vision Care
    Los Angeles, California 90067, United States
  • Wolstan & Goldberg Eye Associates
    Torrance, California 90505, United States
  • Solomon Eye Physicians and Surgeons
    Bowie, Maryland 20716, United States
  • Ophthalmic Partners PC
    Bala-Cynwyd, Pennsylvania 19004, United States
  • MUSC Storm Eye Institute29425
    Charleston, South Carolina 29425, United States
  • Virginia eye consultant
    Norfolk, Virginia 23502, United States
08

References and documents

Publications

  • 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. PubMed 31341799 ↗
  • 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. PubMed 21183100 ↗
  • 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. PubMed 28410714 ↗
  • 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. PubMed 38518990 ↗
  • 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. PubMed 40935225 ↗
  • 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. PubMed 37702522 ↗
  • 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. PubMed 32868880 ↗
  • 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. PubMed 32279436 ↗
  • 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. PubMed 27006324 ↗
  • 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. PubMed 16631051 ↗
  • 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. PubMed 17721503 ↗
  • 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. PubMed 25766733 ↗
  • 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. PubMed 15617892 ↗
  • 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. PubMed 11311626 ↗
  • 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. PubMed 26459996 ↗
  • 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. PubMed 33762815 ↗
  • 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. PubMed 33501377 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2022 to primary completion in Jan 2024, 23 months.

Of 87 non-industry observational studies under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 90. This study's 23 months is below that.

Counting every sponsor, half of 96 studies reached it within 24 months; a quarter within 10 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2022
First posted
Feb 24, 2022
StartActual
Feb 8, 2022
Primary completionActual
Jan 27, 2024
CompletionActual
Jan 27, 2024
Last update
Feb 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05254587
Lead sponsor
Advanced Vision Care
Collaborators
Clinical Research Consultants, Inc.
Responsible party
Sponsor
First posted
Feb 24, 2022
Start date
Feb 8, 2022
Primary completion
Jan 27, 2024
Completion
Jan 27, 2024
Last update
Feb 20, 2026

Study contacts

Nicole Fram, MD
principal investigator · Advanced Vision Care

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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