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CataractNCT07176897

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

An observational study of Cataract and Astigmatism, run by Colvard Kandavel Eye Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Cataract, Astigmatism
What is being tested?
Normal Toric IOL implantation with digital marking
How many people
41 participants
Where
2 sitesUnited States
Study dates
1 Jun 2024to 12 Mar 2025
How long will I take part?
2 Months
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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Los Angeles Ophthalmology General practice all ages > 12 years of age.

Who may be able to join

  • 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)

Who cannot join

  • History of amblyopia
  • History of macular disease
  • History of glaucoma
  • History of corneal disease
  • History of prior corneal surgery
  • History of diabetes
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Colvard-Kandavel Eye Center

    Encino, California, 91316

  • Freedom Vision Surgery Center

    Encino, California, 91316

Other trials in United States

About this study

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

Read the detailed description

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.

Being tested
Normal Toric IOL implantation with digital marking
Keywords
Cataract, Toric, Astigmatism, Digital Marking, Laser cataract surgery, cataract surgery
Medical subject headings
Cataract, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal Toric IOL implantation with digital markingDiagnostic test

    Digital marking was compared to bedside marking, but there was no change in clinical practice. The difference in the marks was measured.

Study groups in NCT07176897
Study groupRoleWhat they receive
Toric Lens PatientsThese patients had selected to have laser cataract surgery with an astigmatism-correcting lens
Receives: Diagnostic Test: Normal Toric IOL implantation with digital marking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. difference in degrees between the digital marker and the manual marker as measured intraoperatively

    Measured: From enrollment to the end of post-operative period at 2 months

Secondary outcomes (4)

  1. IOL rotation

    Measured: From enrollment to the end of post-operative period at 2 months

  2. Residual Astigmatism

    Measured: From enrollment to the end of post-operative period at 2 months

  3. Absolute Prediction Error (APE)

    Measured: From enrollment to the end of post-operative period at 2 months

  4. Monocular Visual Acuity

    Measured: From enrollment to the end of post-operative period at 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start1 Jun 2024
  3. Primary completion12 Mar 2025
  4. Study completion12 Mar 2025

Resources

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
Prospective
Enrolment
41 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176897
Sponsor's protocol ID
9216252
Status last verified
Sep 2025
First submitted
27 Aug 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: This data is not relevant to research outside of the study.

Publications

  • 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.

    PubMed 28732612

  • 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.

    PubMed 19631125

  • 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.

    PubMed 29731603

  • 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.

    PubMed 29056301

  • 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.

    PubMed 31376834

  • 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.

    PubMed 35897093

  • 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.

    PubMed 34074992

  • 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.

    PubMed 22399846

  • 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.

    PubMed 33229690

  • 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.

    PubMed 26402830

  • 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.

    PubMed 35580544

  • 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.

    PubMed 32034232

  • 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.

    PubMed 18812110

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

    PubMed 24837578

  • 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.

    PubMed 19395035

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and Astigmatism, run by Colvard Kandavel Eye Center at 2 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 1 inclusion and 9 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

difference in degrees between the digital marker and the manual marker as measured intraoperatively (time frame: From enrollment to the end of post-operative period at 2 months). 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 NCT07176897, 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 16 Sep 2025.

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