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

NCT05561296 | Unknown

• 1 other identifier: KJR/2022/01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

corneal relaxing incisions; toric IOL; iris registration; femtosecond laser-assisted cataract surgery

Outcome Measures

Primary Outcomes (1)

• Mean postoperative astigmatism

  Mean postoperative astigmatism

  postoperative 3 months

Secondary Outcomes (2)

• Mean monocular uncorrected distance visual acuity

  3 months postoperatively

• Mean monocular corrected distance visual acuity

  3 months postoperatively

Other Outcomes (3)

• Percentage of eyes with residual refractive astigmatism within 0.5 D

  postoperative 3 months

• Proportion of eyes with uncorrected distance visual acuity 20/x or better

  Postoperative 3 months

• Spherical equivalent refractive accuracy

  3 months postoperatively

Study Arms (2)

Astigmatism correction with iris registration guided corneal relaxing incisions

OTHER

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

Astigmatism correction with iris registration guided implantation of toric IOLs

OTHER

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

Interventions

Femtosecond laser assisted cataract surgery with astigmatism management PROCEDURE

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.

Astigmatism correction with iris registration guided corneal relaxing incisions; Astigmatism correction with iris registration guided implantation of toric IOLs

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenneth J Rosenthal: lead
• Johnson & Johnson Surgical Vision, Inc.: collaborator

Study Sites (1)

Kenneth J Rosenthal, MD PC

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Astigmatism; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Study Officials

• Kenneth J Rosenthal, MD

  Kenneth J Rosenthal, MD PC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth J Rosenthal, MD

CONTACT

212 517-4500; research@eyesurgery.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: This prospective, open-label, single-center, non-randomized, interventional study will include 50 patients who will undergo femtosecond laser-assisted cataract surgery (Catalys) and astigmatism correction by either EyHance toric II IOLs or corneal relaxing incisions and implantation of EyHance IOL. The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)