Cataract
Conditions
Brief summary
The purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.
Interventions
PROCEDURELEEP intervention
Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation
PROCEDUREStandard Phaco Control
Sponsors
Iantech, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent. 2. Subjects with a visually significant cataract scheduled to undergo cataract surgery 3. Subjects \> 18 years of age 4. BCVA at baseline not better than 20/40 5. Grade 1+ cataracts
Exclusion criteria
1. Subjects not able to complete the informed consent form 2. Subjects \< 18 years of age 3. Polar cataracts 4. Zonular instability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dispersed Phaco energy | Intraoperative | Total phaco power and energy used as recorded by the phaco machine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial cell loss | 1 month | Change from baseline endothelial cell density as measured by specular microscopy |
Countries
Panama
Contacts
Primary ContactJennifer Gaines
Outcome results
None listed