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Astigmatism Management With Iris-registration Guided Corneal Relaxing Incisions or Toric IOLs During Cataract Surgery

NCT05561296 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-09-30

No results posted yet for this study

Summary

Most of the patients presenting for cataract surgery also have pre-existing corneal astigmatism which if left uncorrected can adversely affect visual and refractive outcomes after cataract surgery. Pre-existing astigmatism at the time of cataract surgery can be corrected by either corneal relaxing incisions or implantation of toric IOLs. While the safety and efficacy of these procedures are well established, there are various challenges associated with these techniques that surgeons need to overcome to achieve good outcomes postoperatively.

The use of iris registration technology that automatically compensates for cyclotorsion has the potential to improve the alignment accuracy of CRI or toric IOLs. The Cassini Ambient and Catalys Femtosecond Laser incorporate this technology to help cataract surgeons accurately align toric IOLs on the intended axis of implantation or accurately place CRI on the intended meridian. The present study is aimed at evaluating the efficacy of astigmatism correction during femtosecond laser-assisted cataract surgery with Catalys femtosecond laser. The patients will either undergo iris registration guided CRIs or iris registration guided alignment of toric IOLs.

Conditions

  • Astigmatism
  • Cataract

Interventions

PROCEDURE

Femtosecond laser assisted cataract surgery with astigmatism management

The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient. Patients will undergo femtosecond laser-assisted cataract surgery with Catalys femtosecond laser.

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    collaborator INDUSTRY

  • Kenneth J Rosenthal

    lead OTHER

Principal Investigators

  • Kenneth J Rosenthal, MD · Kenneth J Rosenthal, MD PC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561296 on ClinicalTrials.gov