Refractive Accuracy of Toric Intraocular Lens Implantation Using Digital Marking Compared to Conventional Marking
NCT ID: NCT07176897
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
41 participants
OBSERVATIONAL
2024-06-01
2025-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Toric Lens Patients
These patients had selected to have laser cataract surgery with an astigmatism-correcting lens
Normal Toric IOL implantation with digital marking
Digital marking was compared to bedside marking, but there was no change in clinical practice. The difference in the marks was measured.
Interventions
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Normal Toric IOL implantation with digital marking
Digital marking was compared to bedside marking, but there was no change in clinical practice. The difference in the marks was measured.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
50 Years
90 Years
ALL
No
Sponsors
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Colvard Kandavel Eye Center
OTHER
Responsible Party
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Ganesha Kandavel
Primary Investigator
Locations
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Colvard-Kandavel Eye Center
Encino, California, United States
Freedom Vision Surgery Center
Encino, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Mozayan E, Lee JK. Update on astigmatism management. Curr Opin Ophthalmol. 2014 Jul;25(4):286-90. doi: 10.1097/ICU.0000000000000068.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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9216252
Identifier Type: -
Identifier Source: org_study_id
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