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

Safety and Efficacy of Astigmatism Correction by Iris-registration Guided Corneal Relaxing Incisions or Toric IOL Implantation During Femtosecond Laser-assisted Cataract Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract; Astigmatism
• Intervention / Treatment: Procedure: Femtosecond laser assisted cataract surgery with astigmatism management

Detailed Description

Surgical correction of astigmatism using corneal relaxing incisions or toric IOLs have been widely adopted to correct pre-existing astigmatism in cataract surgery patients. 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; for instance, correction of astigmatism either with corneal relaxing incisions (CRIs) or toric IOLs during cataract surgery requires appropriate pre-operative planning based on corneal curvature measurements, biometry, nomogram/IOL selection, accurate marking for the placement of CRI/implantation of toric IOL on the intended axis, intraoperative alignment, cyclotorsion compensation, and postoperative IOL rotation, etc.

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. This is expected to improve patients' visual functioning and reduce spectacle dependence postoperatively. The Cassini Ambient provides the preoperative anterior and posterior astigmatism with iris registration. The new Catalys Precision Laser System (Johnson & Johnson Vision) with cOS 6.0 software facilitates direct importation of preoperative data from the Cassini via a wireless connection or USB drive, eliminates the need for manual axis marking as it compares the pre- and intra-operative iris anatomy data and compensates for tilt and rotation so that the laser marks are perfectly aligned to the steep meridian and the target axis. Linking preoperative diagnostic information to the laser minimizes data entry and transcription errors. It also eliminates several steps in the planning process for toric IOLs and CRI, thus improving the overall accuracy of the astigmatism correction procedure and reducing chances for error.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenneth J Rosenthal, MD; Phone Number: 212 517-4500; Email: research@eyesurgery.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Kenneth J Rosenthal, MD PC
      • Contact: Danielle Kramer; Phone Number: 212-517-4500; Email: research@eyesurgery.org
      • Sub-Investigator: Danielle Kramer, BS
      • Sub-Investigator: Alexandra Scherk, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients desirous of undergoing cataract surgery.
• Pre-existing corneal astigmatism requiring either CRIs or toric IOL implantation.
• Patients in whom iris registration link between Cassini Ambient and Catalys femtosecond laser is successful.

Exclusion Criteria:

Patients will be excluded from participating in the study due to any of the following reasons:

• Insufficient pupil dilation to complete Catalys treatment
• Clinically significant corneal pathology precluding reliable Cassini topographical measurement of any cause
• Preoperative corneal astigmatism greater than 4.00 D, or astigmatism requiring both CRIs and implantation of toric intraocular lens for correction.
• Cassini topographical measurement deemed inconsistent with historical topographies and refractive error based on clinical judgment
• Visually significant ocular surface disease (OSD) precluding reliable measurements and/or anticipated to affect refractive stability
• Lid position abnormalities that may affect vision
• Moderate or severe stage glaucoma or optic nerve disease, that would interfere with assessment of or achievement of optimal BCVA
• Visually significant macular disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Astigmatism correction with iris registration guided corneal relaxing incisions; This sub-group will include patients who will undergo femtosecond laser-assisted cataract surgery (Catalys) and astigmatism correction using corneal relaxing incisions and implantation of EyHance IOL. The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient.	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.
Other: Astigmatism correction with iris registration guided implantation of toric IOLs; This sub-group will include patients who will undergo femtosecond laser-assisted cataract surgery (Catalys) and astigmatism correction with the implantation of EyHance toric II IOLs. The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean postoperative astigmatism	Mean postoperative astigmatism	postoperative 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean monocular uncorrected distance visual acuity	Postoperative mean monocular uncorrected distance visual acuity	3 months postoperatively
Mean monocular corrected distance visual acuity	Postoperative mean monocular corrected distance visual acuity	3 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eyes with residual refractive astigmatism within 0.5 D	Frequency distribution of postoperative refractive astigmatism	postoperative 3 months
Proportion of eyes with uncorrected distance visual acuity 20/x or better	Frequency distribution of the proportion of eyes achieving postoperative uncorrected distance visual acuity 20/x or better	Postoperative 3 months
Spherical equivalent refractive accuracy	Proportion of eyes with postoperative MRSE within 0.50 and 1.00 D	3 months postoperatively

Collaborators and Investigators

• Sponsor: Kenneth J Rosenthal
• Collaborators: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Principal Investigator: Kenneth J Rosenthal, MD, Kenneth J Rosenthal, MD PC

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: femtosecond laser-assisted cataract surgery; toric IOL; corneal relaxing incisions; iris registration
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: KJR/2022/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No