Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction
Completed · Not applicable
Conditions studied: Refractive Error - Myopia Severe, Refractive Error - Myopia Simple
In brief
The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.
Key facts
- Study ID
- NCT03021707
- Run by
- Alcon Research
- People needed
- 7
- Starts
- 2017-03-07
- Expected to finish
- 2019-10-17
- Last updated by the study team
- 2022-04-07
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Photopic distance visual acuity worse than best corrected visual acuity (BCVA) 20/400 in the study eye;
- Myopia with manifest refraction spherical equivalent (MRSE) of - 1.50 diopter (D) or higher in the study eye;
- Able to comprehend and provide documented informed consent;
- Willing and able to comply with schedule for follow-up visits;
- Minimum required endothelial cell density (ECD) in study eye as outlined in the protocol;
- Presence of natural lens in study eye;
- A treatment simulation with spectacles or contact lenses on the study eye does not negatively impact participant's daily activities;
- Other protocol-specified inclusion criteria may apply.
You may not qualify if…
- Pregnant or nursing;
- Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator;
- Active implanted device, including but not limited to, heart pacemaker or defibrillator, for which laser use may be a contraindication;
- Current use of medications with known ocular side effects;
- Predicted residual stromal bed thickness <300 micrometers (μm) in study eye
- Ocular conditions in the study eye;
- Previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone;
- Residual, recurrent or active ocular disease that may impact study outcomes;
- Previous or current diagnosis of dry eye;
- Known allergic reaction to medications expected to be used preoperatively, during laser refractive surgery, and for postoperative care;
- Pre-existing corneal opacities in study eye;
- Contact lens worn in study eye and not removed prior to study testing affected by wear per timeframe specified in the protocol;
- Other protocol-specified exclusion criteria may apply.
Where it is running
- Alcon Investigative Site — Sioux Falls, South Dakota, United States
- Alcon Investigative Site — Houston, Texas, United States
- Alcon Investigative Site — Dublin, Ireland
- Alcon Investigative Site — Singapore, Singapore
Full record on ClinicalTrials.gov
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