Clinical Handleability and Acceptability Assessment of the DELTA Disposable Delivery System for Participants with Diagnosis of Cataract

Not Applicable

Completed

• Conditions: Cataract; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12618001876280
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-19
• Study Completion: 2019-08-09
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Be at least 22 years old
• Have a cataract in one or both eyes for which IOL implantation is planned
• Sign an informed consent and any additional documentation required by the governing countries
• Be available, able, and willing to comply with the examination procedures of all study visits.

Exclusion Criteria

• You are already participating in any other clinical study or have participated in a clinical study during the last 45 days
• You have had recent eye trauma or eye surgery that is not resolved
• You have certain medical conditions, such as poorly-controlled diabetes, which may affect your vision
• You have certain known ocular conditions, such as glaucoma which may affect your vision
• Are unable to have an intraocular lens within the available range for the study
• Are pregnant, planning to become pregnant, are lactating or have another condition associated with the fluctuation of hormones that could lead to changes in your vision.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the Rate of Acceptable Overall Clinical Performance.<br>The overall clinical performance of the DELTA Disposable Delivery System will be considered acceptable if the combined percentage of Investigator/Surgeon ratings of 3 or higher on a 5-point scale for acceptable clinical performance is at least 95% based on the responses of the Investigator/Surgeon Per-Eye Day-of-Surgery questionnaire, question #6, How do you rate the overall performance of the DELTA Disposable Delivery System”?<br>[Surgeons will provide an assessment after each cataract surgery to assess the overall clinical performance of the device. ]

Secondary Outcome Measures

Name	Time	Method
il[Nil]