Trials / Completed
CompletedNCT04126174
Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Gainesville Eye Associates · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to compare the effectiveness of LenSx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism.
Detailed description
This study is a comparative, prospective, randomized contralateral eye study of visual outcomes after LenSx laser arcuate relaxing incisions utilizing the Woodcock nomogram at 90% thickness vs. manual (blade) fixed keratome diamond knife at 600 microns for arcuate relaxing incisions utilizing the Donnenfeld nomogram. Subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction and corneal astigmatism measurement with the Lenstar and slit lamp exam.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | femtosecond laser system arcuate corneal incision | Corneal arcuate incision made either with a blade (manual) or femtosecond laser system. |
| OTHER | Manual LRI | Manual LRI |
Timeline
- Start date
- 2019-10-15
- Primary completion
- 2021-03-20
- Completion
- 2021-03-20
- First posted
- 2019-10-15
- Last updated
- 2021-09-05
- Results posted
- 2021-09-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04126174. Inclusion in this directory is not an endorsement.