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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Device
Other interventionThe Perfector is used in the procedure. The device is attached to the participant by the use of a patient attachment. The patient attachment attaches to the sclera of the eye using vacuum pressure.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Application of Perfector laser treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety (common for both cohorts)
The participant will have no serious device adverse event resulting from the treatment. 5% or less with loss of two lines (0.2 logMAR) or more of Corrected Distance Visual Acuity (CDVA).
Time frame
1 month post-treatment to the baseline visit.2
Efficacy for Cohort 1 - Addition of Near Vision
75% of eyes with at least two lines (0.2 logMAR) improvement in Distance Corrected Near Visual Acuity (DCNVA). Participant is assessed by the ETDRS reading chart for near visual acuity at a comfortable reading distance of 40 cm.
Time frame
Between pre-treatment and 1 month post-treatment.3
Efficacy for Cohort 2 - Correction of Refractive Error
75% of eyes with at least two lines (0.2 logMAR) improvement of Uncorrected Distance Visual Acuity (UDVA). Participant is assessed by the ETDRS chart for distance visual acuity at 4 meters.
Time frame
Between pre-treatment and 1 month post-treatment.Secondary outcomes
1
Uncorrected Near Visual Acuity (UNVA) (key in Cohort 1)
Monocular and binocular UNVA distribution at 1 week, 1 month and 3 months post-treatment. 75% of eyes with post-treatment monocular UNVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of participants with post-treatment binocular UNVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of eyes with at least two lines (0.2 logMAR) improvement in UNVA between the pre-treatment and at 3 months post-treatment.
Time frame
Between pre-treatment and 1 week, 1 month and 3 months post-treatment.2
Distance Corrected Near Visual Acuity (DCNVA) (key in Cohort 1)
Monocular and binocular UNVA distribution at 1 week, 1 month and 3 months post-treatment. 75% of eyes with post-treatment monocular DCNVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of participants with post-treatment binocular DCNVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment.
Time frame
1 week, 1 month and 3 months post-treatment.3
Uncorrected Intermediate Visual Acuity (UIVA) (key in Cohort 1)
Monocular and binocular UIVA distribution at 1 week,1 month and 3 months post-treatment. 75% of eyes with post-treatment monocular UIVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of participants with post-treatment binocular UIVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of eyes with at least two lines (0.2 logMAR) improvement in UIVA between pre-treatment and at 3 months post-treatment.
Time frame
Between pre-treatment and 1 week, 1 month and 3 months post-treatment.4
Distance Corrected Intermediate Visual Acuity (DCIVA) (key in Cohort 1)
Monocular and binocular UNVA distribution at 1week, 1 month and three months post-treatment. 75% of eyes with post-treatment monocular DCIVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of participants with post-treatment binocular DCIVA of 20/40 (0.3 logMAR) or better at 3 month post-treatment. 75% of eyes with at least two lines (0.2 logMAR) improvement in DCIVA between pre-treatment and at 3 months post-treatment.
Time frame
Between pre-treatment and 1 week, 1 month and 3 months post-treatment.Other outcomes
1
Slit Lamp Examination Findings
Descriptive analysis of slit lamp examination parameters as e.g., epithelium, stroma, sclera, lens, anterior chamber, fundus.
Time frame
Between pre-treatment and 1 week, 1 month and 3 months post-treatment.2
Intraocular Pressure
Descriptive analysis of intraocular pressure (in mmHg) at post-treatment visits and change from pre-treatment visit in intraocular pressure (in mmHg).
Time frame
Between pre-treatment and 1 week, 1 month and 3 months post-treatment.3
Tear Breakup Time (TBUT)
Descriptive analysis of tear breakup in seconds at post-treatment visits and change from pre-treatment visit.
Time frame
Between pre-treatment and 1 week, 1 month and 3 months post-treatment.4
Endothelium Cell Count
Descriptive analysis of endothelium cell count at post-treatment visits and change from pre-treatment visit.
Time frame
Between pre-treatment and 1 week, 1 month and 3 months post-treatment.Sponsors and contacts
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Source ClinicalTrials.gov
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