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

Status unconfirmed · Not applicable

Conditions studied: Astigmatism, Cataract

In brief

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.

Key facts

Study ID

NCT05561296

Run by

Kenneth J Rosenthal

People needed

50

Starts

2022-09-01

Expected to finish

2023-12-01

Last updated by the study team

2022-09-30

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Kenneth J Rosenthal, MD PC — New York, New York, United States

Full record on ClinicalTrials.gov

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