NCT04082273CompletedNot Applicable
A Single Center, Randomized Control Study to Compare Efficacy and Safety of Femto-laser Created Clear Corneal Incisions with Manually Created Clear Corneal Incisions During Cataract Surgery
Ziemer Ophthalmic Systems AG2 sites in 1 country80 target enrollmentStarted: August 26, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ziemer Ophthalmic Systems AG
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by means of corneal topography Galilei G2
Study Overview
Brief Summary
The aim of this study is to test the hypothesis, that in terms of Surgically Induced corneal Astigmatism (SIA), Higher-order Aberrations (HOA), and wound geometry the femtosecond clear corneal incisions (CCIs) created during cataract surgery are not inferior when compared to manual CCIs.
The potential risks associated with application of the femtosecond laser in this study are no greater or in most cases less than those associated with the standard manual cataract surgical procedure, and the potential benefits (such as precision and reproducibility) are greater than with the standard manual cataract surgery. Therefore, the risk-to-benefit ratio is very low, such that the potential benefits for a subject participating in this study exceed the potential risks
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None (Participant)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation
- •Able to co-operate with the docking system for the femtosecond laser
- •Clear corneal media
- •40 years of age or older
- •Willing and able to return for scheduled follow-up examinations
Exclusion Criteria
- •Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea
- •Maximum K-value that exceeds 58.D
- •Minimal K-value of less than 37.D
- •Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
- •Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
- •Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation
- •Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
- •Known sensitivity to planned concomitant medications
- •History of lens or zonular instability
- •Keratoconus or keratectasia
- •Immune compromised or diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study Pl.
- •Anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured from the corneal endothelium.
- •Extensive corneal scarring, pterygium
- •Developmental disability or cognitive impairment (would preclude adequate comprehension of the IC form and/or the ability to record the study measurements)
- •Concurrent participation in another ophthalmological clinical study
Outcomes
Primary Outcomes
Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by means of corneal topography Galilei G2
Time Frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
Secondary Outcomes
- Change from baseline (pre-operative) Higher-order aberrations (HOAs) by means of aberrometry using Galilei G2(Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery)
- Central corneal thickness (CCT)(Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery)
- Endothelial cell density (ECD)(Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery)
- Effective Phacoemulsification Time (EPT)(Baseline = Treatment day)
- Ultrasound total time (US)(Baseline = Treatment day)
- Achieved CCI architecture(1 day postoperative and 12 days postoperative)
- Intra- and post-operative CCI related complications rate(Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery)
- FEMTO LDV Z8 OCT auto - detection accuracy(Baseline = Treatment day)
Investigators
Study Sites (2)
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