Health Condition 1: H269- Unspecified cataract
Conditions
Interventions
Intervention1: The Atlas F-0200 Device: The Atlas F-0200 is an advanced handheld capsulotomy device specifically engineered for precision anterior capsulotomy during cataract surgery. At the heart of
Sponsors
Sathyan Eye Care Hospital & Coimbatore Glaucoma Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects must be 18 years of age or older on the date the ICF was signed. 2.Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF. 3.Subjects must have a clinically significant operable cataract(cortical, nuclear, subcapsular, or combination) as determined by the medical judgement of the Investigator, in at least one eye that is considered amenable to treatment with phacoemulsification or lens softening cataract extraction and capsular IOL implantation. 4. Subjects must have clear cornea and normal anterior and posterior segment. 5. Subjects must be willing and able to comply with all treatment and follow-up study visits and procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects who have used an investigational drug or device within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation. 2. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the study eye. 3. Subjects who have significant anterior segment pathology that might increase intraoperative risk (e.g., pseudoexfoliation, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in the study eye. 4. Subjects who have uncontrolled glaucoma in the study eye. 5. Subjects who have active proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy in the study eye.6. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in the study eye. 7. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in the study eye. 8. Subjects who have had previous corneal surgery in the study eye. 9. Subjects with any active preoperative infectious conjunctivitis,keratitis, or uveitis in either eye within 30 days prior to surgery. 10. Surgeon to assess dilation and decide if the patient has adequate dilation (approx. 6.0mm --subjective assessment by surgeon) 11. Subjects with abnormal pupillary dilation dynamics (as determined by the medical judgement of the investigator) or eccentric or ectopic pupils in either eye. 12. Subjects who may be expected to require a combined or other secondary surgical procedure in the study eye. 13. Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the study if they are nursing, lactating, currently pregnant or plan to become pregnant during the study. Females of childbearing potential must be willing to practice effective contraception for the duration of the study. 14. Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstances that, based on the Investigator s judgement, poses a concern for the subjects safety or could confound the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)incidence of adverse events; b)Slit lamp findings.Timepoint: 1)Screening (-60 to -1 day) 2)Operative: (0 day) 3)Day 1: (1 day) 4)Week 1: (5-9 days) 5)Week 4: (21-35 days) 6)6 months 7)1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| a)Complete capsulotomy b)Completed removal of the cataractous lens.Timepoint: 1)Screening (-60 to -1 day) 2)Operative: (0 day) 3)Day 1: (1 day) 4)Week 1: (5-9 days) 5)Week 4: (21-35 days) 6)6 months 7)1 year | — |
Countries
India
Contacts
Public ContactDr P Sathyan
Sathyan Eye Care Hospital & Coimbatore Glaucoma Foundation
Outcome results
None listed