Clinical Outcomes of the Use of a Femtosecond Laser Treatment in a Patient With Implanted Monofocal IOLs
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPerfect Lens, LLC
About this trial
This study aims to assess the safety and efficacy of evaluating near vision or refractive error in eyes implanted with a mono focal intraocular lens (IOL) using a low-energy femtosecond laser.
Eligibility criteria
Qualifiers
Ability to understand study requirements, follow study instructions and to return for required study follow-up visits as confirmed by provision of written informed consent.
Participant has undergone cataract surgery with an implantation of mono focal IOL.
Participant has no significant residual visual issues which the Investigator believes would make the patient ill-suited for the treatment.
Vision must be clinically stable in the Investigator's judgment.
Disqualifiers
Participants not able to complete the informed consent form.
Clinically significant corneal abnormalities including corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), inflammation, keratitis, keratoconjunctivitis, keratouveitis, keratopathy, keratectasia or edema per the Investigator's expert medical opinion.
Previous corneal surgery.
Previous refractive surgery or proposed refractive surgery procedures throughout the entire duration of the participants' participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions).
Trial design
Treatments tested in this trial
- Device
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov