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

C

Colvard Kandavel Eye Center

Status

Completed

Conditions

Cataract
Astigmatism

Treatments

Diagnostic Test: Normal Toric IOL implantation with digital marking

Study type

Observational

Funder types

Other

Identifiers

NCT07176897
9216252

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Trial design

41 participants in 1 patient group

Toric Lens Patients
Description:
These patients had selected to have laser cataract surgery with an astigmatism-correcting lens
Treatment:
Diagnostic Test: Normal Toric IOL implantation with digital marking

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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