MyopiaNCT05254587
Accuracy of IOLMASTER 700 Total Keratometry (TK)
An observational study of Myopia and Hyperopia, run by Advanced Vision Care at 7 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- IOLMASTER 700 TK
- Type of treatment
- Medical device
- How many people
- 155 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Feb 2022to 27 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Empire Eye & Laser Center
Bakersfield, California, 93309
Ophthalmic Partners PC
Bala-Cynwyd, Pennsylvania, 19004
Solomon Eye Physicians and Surgeons
Bowie, Maryland, 20716
MUSC Storm Eye Institute29425
Charleston, South Carolina, 29425
Advanced Vision Care
Los Angeles, California, 90067
Virginia eye consultant
Norfolk, Virginia, 23502
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
About this study
Official title: 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.
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.
- Being tested
- IOLMASTER 700 TK
- Keywords
- Laser Vision Correction, Cataract Surgery
- Medical subject headings
- Myopia, Hyperopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOLMASTER 700 TKDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Not described Receives: Device: IOLMASTER 700 TK | |
| Prospective | Not described Receives: Device: IOLMASTER 700 TK |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start8 Feb 2022
- Primary completion27 Jan 2024
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Vision Care
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research Consultants, Inc.
- Responsible party
- Sponsor
- Investigators
- Nicole Fram, MD, Principal investigator, Advanced Vision Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254587
- Sponsor's protocol ID
- AVC-005
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2022
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 31341799Aristodemou 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 21183100Kane 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 28410714Anter 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 38518990Suraneni 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 40935225Kenny 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 37702522Yeo 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 32868880Lawless 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 32279436Abulafia 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 27006324Masket 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 16631051Gale 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 17721503Fram 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 25766733Ladas 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 15617892Gimbel 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 11311626Wang 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of IOLMASTER 700 Total Keratometry (TK) in Patients Undergoing Post-Laser Vision Correction Cataract Surgery
- ClinicalTrials.gov ID
- NCT05254587
- Acronym / sponsor ID
- AVC-005
- Keywords
- Laser Vision Correction, Cataract Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Advanced Vision CareUniversity, hospital or other
- Collaborators
- Clinical Research Consultants, Inc.
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Device: IOLMASTER 700 TK |
| Prospective | – | Device: IOLMASTER 700 TK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- Patients with a history of any of the following:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOLMASTER 700 TK4 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. | Device | Prospective, Retrospective |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 31341799Moshirfar 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.
- Background: PubMed 21183100Aristodemou 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.
- Background: PubMed 28410714Kane 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.
- Background: PubMed 38518990Anter 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.
- Background: PubMed 40935225Suraneni 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.
- Background: PubMed 37702522Kenny 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.
- Background: PubMed 32868880Yeo 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.
- Background: PubMed 32279436Lawless 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.
- Background: PubMed 27006324Abulafia 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.
- Background: PubMed 16631051Masket 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.
- Background: PubMed 17721503Gale 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.
- Background: PubMed 25766733Fram 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Fram, MD principal investigator
Advanced Vision Care
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Hyperopia, run by Advanced Vision Care at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Keratometry Accuracy Assessment (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254587, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.