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| Name | Class |
|---|---|
| Clinical Research Consultants, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective |
| ||
| Prospective |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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).
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.
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Fram, MD | Advanced Vision Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye & Laser Center | Bakersfield | California | 93309 | United States | ||
| Advanced Vision Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31341799 | Background | 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. | |
| 21183100 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| 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 |
| 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. |
| 28410714 | 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. |
| 38518990 | 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. |
| 40935225 | 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. |
| 37702522 | 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. |
| 32868880 | 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. |
| 32279436 | 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. |
| 27006324 | 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. |
| 16631051 | 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. |
| 17721503 | 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. |
| 25766733 | 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. |
| 15617892 | 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. |
| 11311626 | 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. |
| 26459996 | 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. |
| 33762815 | 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. |
| 33501377 | 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. |