None listed
Conditions
Brief summary
This research study is being conducted in order to gather information about the overall clinical performance and ease-of-use of the DELTA Disposable Delivery System, an instrument used in cataract surgery to implant the intraocular lens (IOL) into the eye. Delivery systems are commonly used in cataract surgery, this study is simply testing a new type of delivery system. Intraocular lenses are implanted as part of routine cataract surgery to restore vision.
Interventions
All subjects who meets the eligibility criteria will be invited to participate in the study. The study doctor will determine which eye(s) will be eligible based on the inclusion/exclusion criteria. Those participants who meet the inclusion/exclusion criteria and agree to participate will be scheduled for surgery to be unilaterally or bilaterally implanted with the TECNIS ZCB00 IOL. Participants will be enrolled at each site sequentially until the recruitment goals are met or the site limit is re
All subjects who meets the eligibility criteria will be invited to participate in the study. The study doctor will determine which eye(s) will be eligible based on the inclusion/exclusion criteria. Those participants who meet the inclusion/exclusion criteria and agree to participate will be scheduled for surgery to be unilaterally or bilaterally implanted with the TECNIS ZCB00 IOL. Participants will be enrolled at each site sequentially until the recruitment goals are met or the site limit is reached. Inclusion of qualified second eyes in the study, for those being bilaterally implanted, will occur at the investigator’s discretion if within the overall study enrollment period. Your study doctor will perform the cataract surgery at the surgery center. The investigator should use his or her standard, small-incision (2.2 – 2.4mm) cataract extraction surgical technique. Lenses should be inserted into the capsular bag using the DELTA Disposable Delivery System. Surgery can take 15-20 minutes in duration. The study visits for each eye are outlined below: Visit 1 – Preoperative Exam to be completed within 45 days prior to surgery Visit 2 – Operative Visit to be completed the day of the operation Visit 3 – 1-Day Postoperative Visit to be completed 1-2 days following surgery For first surgeries, a representative from Sponsor will be present in the operating room for direct observation.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed