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Procedure
Astigmatism Management during Cataract Surgery for Cataract with Astigmatism
N/A
Waitlist Available
Led By Kenneth J Rosenthal, MD
Research Sponsored by Kenneth J Rosenthal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will help to improve the accuracy of astigmatism correction during cataract surgery, leading to better visual outcomes for patients.
Eligible Conditions
- Cataract
- Astigmatism
- Pseudoaphakia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean postoperative astigmatism
Secondary study objectives
Mean monocular corrected distance visual acuity
Mean monocular uncorrected distance visual acuity
Other study objectives
Percentage of eyes with residual refractive astigmatism within 0.5 D
Proportion of eyes with uncorrected distance visual acuity 20/x or better
Spherical equivalent refractive accuracy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Astigmatism correction with iris registration guided implantation of toric IOLsExperimental Treatment1 Intervention
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.
Group II: Astigmatism correction with iris registration guided corneal relaxing incisionsExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Johnson & Johnson Surgical Vision, Inc.Industry Sponsor
36 Previous Clinical Trials
8,305 Total Patients Enrolled
31 Trials studying Cataract
7,076 Patients Enrolled for Cataract
Kenneth J RosenthalLead Sponsor
Kenneth J Rosenthal, MDPrincipal InvestigatorKenneth J Rosenthal, MD PC
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant eye condition that could affect the accuracy of measurements or make it difficult to maintain stable vision.You want to have cataract surgery.You cannot participate in the study if you have any of the following:You have an eye condition that makes it difficult to accurately measure the shape of your cornea using the Cassini device.You have an abnormality in the position of your eyelids that could affect your vision.You have a pre-existing eye condition called corneal astigmatism that requires special contact lenses or a specific type of lens implant.
Research Study Groups:
This trial has the following groups:- Group 1: Astigmatism correction with iris registration guided corneal relaxing incisions
- Group 2: Astigmatism correction with iris registration guided implantation of toric IOLs
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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