Cataract
Conditions
Brief summary
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification.
Detailed description
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification to evaluate safety and effectiveness. The primary effectiveness endpoint is a complete capsulotomy in at least 95 percent of the cases. The primary safety endpoint is posterior capsular rupture and virtuous loss in 4 percent or less of the subjects. Other parameters to be captured during the study include anterior capsule tears, corneal touch, capsulotomy diameter, contraption of the Zepto capsulotomy, size of the corneal incision pre and post Zepto, interocular lens contraption and evaluation of zonular stability and the incidence and severity of adverse events. The criteria for patient success will be accessed based on the successful completion of a 360 degree capsulotomy without tissue bridges and no posterior capsule rupture and vitreous loss. The criteria for study success will be accessed based on a greater than or equal to 95 percent of the cases having a complete 360 degree capsulotomy without tissue bridges and less than 4 percent of subjects with posterior capsule rupture and vitreous loss.
Interventions
DEVICEZepto System
Anterior Capsulotomy using the Zepto System.
Sponsors
Mynosys Cellular Devices, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be age 22 or older, 2. Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age related lens cataract, and then electing to undergo ZeptoTM capsulotomy, 3. Subjects must be willing and able to return for scheduled treatment and follow-up examinations for 3 months.
Exclusion criteria
1. Disease or pathology in the treatment eye that will compromise visual performance or refractive outcome (e.g. previous refractive surgery), 2. Zonular abnormality, 3. Posterior polar cataract, 4. Fellow eye with acuity less than 20/200, 5. Any prior ocular surgery of the study eye, 6. Pupillary dilation during the pre-operative exam of less than 7 mm in diameter, 7. Proliferative diabetic retinopathy, 8. Disorders of the ocular muscles, such as nystagmus or strabismus, 9. Chronic uveitis, 10. Abnormal corneal endothelium, 11. Subjects on medications with, in the opinion of the surgeon, significant ocular side effects, 12. Pregnant or nursing (lactating) women, 13. Implanted ocular device or drug in the study eye, 14. Any other condition, which in the judgment of the investigator would prevent the subject from completing the study (e.g. documented diagnosis or treatment for symptoms associated with dementia, mental illness), 15. Current participation in another drug or device clinical study, or participation in such a clinical study within the six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Capsulotomy | During surgery | A successful complete Zepto capsulotomy is defined in this protocol to be one that results in a complete 360 degree capsulotomy without any residual tissue bridges visible to the surgeon. If there are such tissue bridges, the surgeon completes the capsulotomy manually. The primary effectiveness endpoint was defined as :Complete capsulotomy (target ≥ 95% of cases). |
Participant flow
Recruitment details
This study enrolled patients at 8 clinical study sites, with symptomatic age-related lens cataract desiring lens extraction and IOL implantation. The last patient was enrolled in the study in December 2016.
Participants by arm
| Arm | Count |
|---|---|
| Zepto Capsulotomy This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture & Vitreous Loss (4% or less)
Zepto System: Anterior Capsulotomy using the Zepto System. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Zepto Capsulotomy |
|---|---|
| Age, Customized | 69.4 years |
| Best spectacle corrected distance visual acuity (BSCVA) | 40 ft |
| Dilated Pupil Size | 8 mm |
| Fundus Examination % presented with posterior vitreous detachment | 7 percentage of participants |
| Fundus Examination % with a tilted disc | 1 percentage of participants |
| Fundus Examination % with choroidal nevus | 1 percentage of participants |
| Fundus Examination % with mild epiretinal membrane | 1 percentage of participants |
| Fundus Examination % with mild macular drusen | 1 percentage of participants |
| Fundus Examination % with normal findings | 87 percentage of participants |
| Fundus Examination % with peripheral drusen | 1 percentage of participants |
| Fundus Examination % with post vitreous degeneration | 1 percentage of participants |
| Intraocular Pressure | 16 mm Hg |
| Manifest Refraction | 96 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 92 Participants |
| Region of Enrollment United States | 100 Participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 42 Participants |
| Slit Lamp % 1 + punctuate epithelial keratitis/ keratopathy | 1 percentage of participants |
| Slit Lamp % of Normal cornea | 97 percentage of participants |
| Slit Lamp % of Normal treatment lids | 97 percentage of participants |
| Slit Lamp % presenting with 1 + Meibomian gland dysfunction | 7 percentage of participants |
| Slit Lamp % with faint stromal scarring | 1 percentage of participants |
| Slit Lamp % with Waite Beecham Lines - mild | 1 percentage of participants |
| Uncorrected distance visual acuity (UCVA) | 138 ft |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 5 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Complete Capsulotomy
A successful complete Zepto capsulotomy is defined in this protocol to be one that results in a complete 360 degree capsulotomy without any residual tissue bridges visible to the surgeon. If there are such tissue bridges, the surgeon completes the capsulotomy manually. The primary effectiveness endpoint was defined as :Complete capsulotomy (target ≥ 95% of cases).
Time frame: During surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zepto Capsulotomy | Complete Capsulotomy | 98 participants |