Clinical Outcomes of Femtosecond Laser Presbyopia Treatment in Monofocal IOLs

Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using the manifest refraction and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 40 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

The hypothesis tested for is to demonstrate superiority of the near vision of treated IOL to the IOL pre-treatment.

Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using the manifest refraction and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 66 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

The hypothesis tested for is to demonstrate non-inferiority of the treated IOL to the pre-treated IOL (using a non-inferiority margin of 0.10 logMAR).

Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using the manifest refraction adjusted for infinity and stand Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 4 meters (m) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

The hypothesis tested for the co-primary effectiveness endpoint is to demonstrate non-inferiority of the treated IOL to the pre-treatment IOL (using a non-inferiority margin of 0.10 logMAR).

Visual acuity (VA) was tested monocularly and binocularly (both eyes together) adjusted for infinity and stand Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 4 meters (m) on the nearpoint rod. Without the manifest refraction. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 66 centimeters (cm) on the nearpoint rod. Without manifest refraction. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 40 centimeters (cm) on the nearpoint rod. Without manifest refraction. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using manifest refraction100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 40 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

To assess the defocus curve the same optotype as for the distance visual acuity will be used. The test will be performed with the best distance corrected refraction and spherical additions between -5.0 D to +1.5 D in 0.5 D steps. Defocus curve will be performed monocularly. The patient will be presented with the spherical additions in the order from -5.0 D to +1.5 D.

Contrast sensitivity testing will be performed monocularly with the distance-corrected study eye under photopic with glare, mesopic and mesopic with glare conditions using CSV 1000. The testing will be performed at spatial frequencies of 3, 6, and 12 and 18 cycles/degree.

Mesopic contrast sensitivity testing (3 cd/m2) using mesopic filter installed in the patient trial frame, will be performed prior to the photopic testing (85 cd/m2). A minimum of 5 minutes should be provided for the patient's eye dark adaptation before the beginning of the mesopic contrast testing in a room with photopic light conditions.

The ambient illumination should be lower or at most equal to the chart luminance. The mesopic testing without glare will be performed first before testing with glare source provided with the testing device

The assessment of refraction, which includes sphere (D), cylinder (D), and axis (°), will be conducted through subjective and objective methods. Objective refraction will follow standard clinical practice and will be performed by the Investigator or trained staff. Subjective testing will be conducted using trial frames instead of a phoropter. Consistency in the refractive technique should be maintained throughout the entire study duration. Test optotypes such as Sloan letters (e.g., ETDRS charts) will be used.

The cylinder value should be recorded in negative notation. Cylinder refraction should be performed for every patient. If the cylinder refraction is zero, the cylinder axis should be marked as not applicable. A pre-sign for the sphere is only necessary for negative values. If no pre-sign is entered, it indicates a positive value

Monocular CNVA with near addition. Designed to create additional foci in the implanted IOL which will give near vision without loss of far vision.

Slit lamp examination will be performed using a slit lamp biomicroscope. The subject will be seated. During this examination the eyes might be dilated depending on doctors' decision. The following will be examined during the examination conjunctiva, cornea, anterior chamber, iris, eyelid. Magnification will be consistent with standard clinical practise.

The observation will be graded as normal or abnormal. In case of abnormal observations subjective graded according to the grading scales will be used. The abnormal grading will then be graded as clinical significant or not clinically significant. In case of clinically significant observation the event will be specified and will be collected as adverse events.

To examine the retinal integrity and document the safety of the procedure a full fundus examination will be performed using a slit lamp and dilated pupil for a clear view.

The intraocular pressure (IOP) will be measured using air tonometry

The questionnaire in the Czech language will be explained to the patient and handed over by the staff. It consists of 9 questions with multiple-choice answers as standard.

The questions request answers on the following scale: All the time / Most of the time / Sometimes / Rarely / Never.

The best response is never.

The questionnaire in the Czech language will be explained to the patient and handed over by the staff. It consists of 10 questions as standard. All of the questions have 4 possible answers: Never / Occasionally / Often / Frequently. The worst outcome is frequently.

During the course of the planned clinical investigation, utmost attention will be given to detecting any potential adverse events or unfavourable discoveries.All findings related to adverse events must be documented in the "Adverse Event (AE)" section of the subject's worksheets (CRFs). These events are categorized as either serious or non-serious, as well as related or unrelated to the investigational device/procedure. The method of reporting or documenting these adverse events varies depending on their category (serious or non-serious).

An inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety usability, safety or performance. Device deficiencies include includes malfunctions, use errors, and inadequacy in the information supplied by the manufacturer including labelling. This definition includes device deficiencies related to the investigational medical device. DD can become (might lead to) serious adverse events (SAE) if:

• suitable action had not been taken, or
• intervention had not been made, or
• if circumstances had been less fortunate These DDs are handled using the SAE reporting system.