Refractive Accuracy of Toric Intraocular Lens Implantation Using Digital Marking Compared to Conventional Marking

NCT07176897 | Completed FDA Device

• 1 other identifier: 9216252
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the postoperative refractive accuracy and intraoperative lens rotational placement of a conventional toric intraoperative marking method compared to digital marking.

Conditions

Cataract; Astigmatism

Keywords

Cataract; Toric; Astigmatism; Digital Marking; Laser cataract surgery; cataract surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

Study Arms (1)

Toric Lens Patients

These patients had selected to have laser cataract surgery with an astigmatism-correcting lens

Diagnostic Test: Normal Toric IOL implantation with digital marking

Interventions

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.

Toric Lens Patients

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Los Angeles Ophthalmology General practice all ages \> 12 years of age.

You may qualify if:

• Adults (50-90 years of age) that were candidates for uncomplicated cataract surgery and planned to be implanted with toric IOLs (CCWOTx, Alcon Vision, LLC)

You may not qualify if:

• History of amblyopia
• History of macular disease
• History of glaucoma
• History of corneal disease
• History of prior corneal surgery
• History of diabetes
• History of ocular comorbidity that might hamper post operative visual acuity
• History of previous ocular or refractive surgery with expected post-op VA worse than 0.10 logMAR
• History of irregular corneal astigmatism and keratoconus, or severe/uncontrolled ocular surface disease or dry eye disease.

Sponsors & Collaborators

• Colvard Kandavel Eye Center: lead

Study Sites (2)

Colvard-Kandavel Eye Center

Encino, California, 91316, United States

Location

Freedom Vision Surgery Center

Encino, California, 91316, United States

Location

Related Publications (17)

• 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.

  PMID: 28732612 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.

  PMID: 19631125 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.

  PMID: 29731603 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.

  PMID: 29056301 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.

  PMID: 31376834 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.

  PMID: 35897093 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.

  PMID: 34074992 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.

  PMID: 22399846 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.

  PMID: 33229690 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.

  PMID: 26402830 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.

  PMID: 35580544 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.

  PMID: 32034232 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.

  PMID: 18812110 BACKGROUND

• Mozayan E, Lee JK. Update on astigmatism management. Curr Opin Ophthalmol. 2014 Jul;25(4):286-90. doi: 10.1097/ICU.0000000000000068.

  PMID: 24837578 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.

  PMID: 19395035 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.

  PMID: 9584246 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.

  PMID: 34290195 BACKGROUND

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 16, 2025
• Study Start: June 1, 2024
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)