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To evaluate the postoperative refractive accuracy and intraoperative lens rotational placement of a conventional toric intraoperative marking method compared to digital marking.
Preoperative biometry and planning was assessed with the Argos SS-OCT biometer. The ToriCAM application was also used to mark the patient manually at the bedside. A Mendez marker was used to mark the final axis of the IOL, as calculated by Argos. Digital marking was performed using the VERION image guided system. All subjects received both digital and manual marking, and were implanted with Clareon monofocal toric IOLs (CCWOTx) using the digital marker for final IOL alignment. The primary outcome measure was the difference in degrees between the digital marker and the manual marker as measured intraoperatively. Other outcome measures included IOL rotation, residual astigmatism, absolute prediction error (APE), and monocular visual acuity at 2 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toric Lens Patients | These patients had selected to have laser cataract surgery with an astigmatism-correcting lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Toric IOL implantation with digital marking | Diagnostic Test | Digital marking was compared to bedside marking, but there was no change in clinical practice. The difference in the marks was measured. |
| Measure | Description | Time Frame |
|---|---|---|
| difference in degrees between the digital marker and the manual marker as measured intraoperatively | From enrollment to the end of post-operative period at 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| IOL rotation | From enrollment to the end of post-operative period at 2 months | |
| Residual Astigmatism | From enrollment to the end of post-operative period at 2 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Los Angeles Ophthalmology General practice all ages > 12 years of age.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colvard-Kandavel Eye Center | Encino | California | 91316 | United States | ||
| Freedom Vision Surgery Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28732612 | Background | Webers VSC, Bauer NJC, Visser N, Berendschot TTJM, van den Biggelaar FJHM, Nuijts RMMA. Image-guided system versus manual marking for toric intraocular lens alignment in cataract surgery. J Cataract Refract Surg. 2017 Jun;43(6):781-788. doi: 10.1016/j.jcrs.2017.03.041. | |
| 19631125 | Background | Rozema JJ, Gobin L, Verbruggen K, Tassignon MJ. Changes in rotation after implantation of a bag-in-the-lens intraocular lens. J Cataract Refract Surg. 2009 Aug;35(8):1385-8. doi: 10.1016/j.jcrs.2009.03.037. |
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This data is not relevant to research outside of the study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2024 | Aug 27, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2024 | Aug 27, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| Absolute Prediction Error (APE) |
| From enrollment to the end of post-operative period at 2 months |
| Monocular Visual Acuity | From enrollment to the end of post-operative period at 2 months |
| Encino |
| California |
| 91316 |
| United States |
| 29731603 | Background | Titiyal JS, Kaur M, Jose CP, Falera R, Kinkar A, Bageshwar LM. Comparative evaluation of toric intraocular lens alignment and visual quality with image-guided surgery and conventional three-step manual marking. Clin Ophthalmol. 2018 Apr 24;12:747-753. doi: 10.2147/OPTH.S164175. eCollection 2018. |
| 29056301 | Background | Mayer WJ, Kreutzer T, Dirisamer M, Kern C, Kortuem K, Vounotrypidis E, Priglinger S, Kook D. Comparison of visual outcomes, alignment accuracy, and surgical time between 2 methods of corneal marking for toric intraocular lens implantation. J Cataract Refract Surg. 2017 Oct;43(10):1281-1286. doi: 10.1016/j.jcrs.2017.07.030. Epub 2017 Oct 19. |
| 31376834 | Background | Kim EC, Hwang KY, Lim SA, Yi R, Joo CK. Accuracy of toric intraocular lens implantation using automated vs manual marking. BMC Ophthalmol. 2019 Aug 3;19(1):169. doi: 10.1186/s12886-019-1175-1. |
| 35897093 | Background | Ding N, Wang X, Song X. Digital versus slit-beam marking for toric intraocular lenses in cataract surgery. BMC Ophthalmol. 2022 Jul 27;22(1):323. doi: 10.1186/s12886-022-02548-y. |
| 34074992 | Background | Barbera-Loustaunau E, Basanta I, Vazquez J, Duran P, Costa M, Counago F, Garzon N, Angel Sanchez-Tena M. Time-efficiency assessment of guided toric intraocular lens cataract surgery: pilot study. J Cataract Refract Surg. 2021 Dec 1;47(12):1535-1541. doi: 10.1097/j.jcrs.0000000000000688. |
| 22399846 | Background | Lehmann RP, Houtman DM. Visual performance in cataract patients with low levels of postoperative astigmatism: full correction versus spherical equivalent correction. Clin Ophthalmol. 2012;6:333-8. doi: 10.2147/OPTH.S28241. Epub 2012 Mar 2. |
| 33229690 | Background | Kodavoor SK, Divya J, Dandapani R, Ramamurthy C, Ramamurthy S, Sachdev G. Randomized trial comparing visual outcomes of toric intraocular lens implantation using manual and digital marker. Indian J Ophthalmol. 2020 Dec;68(12):3020-3024. doi: 10.4103/ijo.IJO_465_20. |
| 26402830 | Background | Elhofi AH, Helaly HA. Comparison Between Digital and Manual Marking for Toric Intraocular Lenses: A Randomized Trial. Medicine (Baltimore). 2015 Sep;94(38):e1618. doi: 10.1097/MD.0000000000001618. |
| 35580544 | Background | Shin DE, Lee JM, Kim TI, Seo KY, Koh K. Efficacy of the Image-Guided Alignment System for a Four-Haptic Hydrophobic Monofocal Toric Intraocular Lens. Eye Contact Lens. 2022 Sep 1;48(9):396-402. doi: 10.1097/ICL.0000000000000901. Epub 2022 May 17. |
| 32034232 | Background | Terauchi R, Horiguchi H, Ogawa T, Shiba T, Tsuneoka H, Nakano T. Posture-related ocular cyclotorsion during cataract surgery with an ocular registration system. Sci Rep. 2020 Feb 7;10(1):2136. doi: 10.1038/s41598-020-59118-9. |
| 18812110 | Background | Ma JJ, Tseng SS. Simple method for accurate alignment in toric phakic and aphakic intraocular lens implantation. J Cataract Refract Surg. 2008 Oct;34(10):1631-6. doi: 10.1016/j.jcrs.2008.04.041. |
| 24837578 | Background | Mozayan E, Lee JK. Update on astigmatism management. Curr Opin Ophthalmol. 2014 Jul;25(4):286-90. doi: 10.1097/ICU.0000000000000068. |
| 19395035 | Background | Nubile M, Carpineto P, Lanzini M, Calienno R, Agnifili L, Ciancaglini M, Mastropasqua L. Femtosecond laser arcuate keratotomy for the correction of high astigmatism after keratoplasty. Ophthalmology. 2009 Jun;116(6):1083-92. doi: 10.1016/j.ophtha.2009.01.013. Epub 2009 Apr 23. |
| 9584246 | Background | Budak K, Friedman NJ, Koch DD. Limbal relaxing incisions with cataract surgery. J Cataract Refract Surg. 1998 Apr;24(4):503-8. doi: 10.1016/s0886-3350(98)80292-7. |
| 34290195 | Background | Schallhorn SC, Hettinger KA, Pelouskova M, Teenan D, Venter JA, Hannan SJ, Schallhorn JM. Effect of residual astigmatism on uncorrected visual acuity and patient satisfaction in pseudophakic patients. J Cataract Refract Surg. 2021 Aug 1;47(8):991-998. doi: 10.1097/j.jcrs.0000000000000560. |