The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic (Artiplus) intraocular lens.
The study is a prospective, open-label, single-arm, and multicentre clinical investigation with three years of follow-up. Artiflex Presbyopic (Artiplus) is a phakic intraocular lens to be implanted in the anterior chamber, intended for adult subjects and indicated for the optical correction of presbyopia and spherical error requiring a correction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Implantation of iris-fixated multifocal Artiflex Presbyopic IOL (Artiplus)
GM st. Mary's Eye clinic
Busan, South Korea
Nune Eye Hospital Daegu
Seoul, South Korea
SU Yonsei Eye Clinic
Seoul, South Korea
ICQO
Bilbao, Biscay, Spain
Improvement in monocular and binocular uncorrected near visual acuity (UNVA)
* Percentage of eyes that achieve UNVA of 0.3 logMAR or better * Percentage of eyes that achieve UNVA of 0.0 logMAR or better
Time frame: 3 years
Improvement in monocular and binocular corrected near visual acuity (CNVA)
* Percentage of eyes that achieve CNVA of 0.3 logMAR or better * Percentage of eyes that achieve CNVA of 0.0 logMAR or better
Time frame: 3 years
Improvement in monocular and binocular distance corrected near visual acuity (DCNVA)
* Percentage of eyes that achieve DCNVA of 0.3 logMAR or better * Percentage of eyes that achieve DCNVA of 0.0 logMAR or better
Time frame: 3 years
Improvement in monocular and binocular uncorrected intermediate visual acuity (UIVA)
* Percentage of eyes that achieve UIVA of 0.3 logMAR or better * Percentage of eyes that achieve UIVA of 0.0 logMAR or better
Time frame: 3 years
Improvement in monocular and binocular distance corrected intermediate visual acuity (DCIVA)
* Percentage of eyes that achieve DCIVA of 0.3 logMAR or better * Percentage of eyes that achieve DCIVA of 0.0 logMAR or better
Time frame: 3 years
Improvement in monocular and binocular uncorrected distance visual acuity (UDVA)
Percentage of eyes that achieve UDVA of 0.3 logMAR or better Percentage of eyes that achieve UDVA of 0.0 logMAR or better
Time frame: 3 years
Improvement in monocular and binocular corrected distance visual acuity (CDVA)
* Percentage of eyes that achieve CDVA of 0.3 logMAR or better * Percentage of eyes that achieve CDVA of 0.0 logMAR or better
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IMO
Barcelona, Catalonia, Spain
Hospital San Rafael
Madrid, Spain
CIMO
Seville, Spain
Time frame: 3 years
Defocus evaluation
Binocular defocus evaluation will be obtained by using the best-corrected distance refraction and then defocusing the image in 0.5 D increments from +1.5 to -5.0 D
Time frame: 3 years
Predictability of the manifest refraction spherical equivalent (MRSE)
The absolute difference between the actually obtained MRSE and the target MRSE
Time frame: 3 years
Predictability of the manifest refraction spherical equivalent (MRSE)
The percentage of eyes that achieves a MRSE of less than or equal to 0.5 D difference between the actual and target MRSE
Time frame: 3 years
Predictability of the manifest refraction spherical equivalent (MRSE)
The percentage of eyes that achieves a MRSE of less than or equal to 1.0 D difference between the actual and target MRSE
Time frame: 3 years
Stability of manifest refraction spherical equivalent (MRSE)
Mean change in MRSE between visits as determined by a paired analysis
Time frame: 3 years
Stability of manifest refraction spherical equivalent (MRSE)
The percentage of eyes that achieves a change in MRSE of less than or equal to 0.5 D between two consecutive refraction measurements
Time frame: 3 years
Stability of manifest refraction spherical equivalent (MRSE)
The percentage of eyes that achieves a change in MRSE of less than or equal to 1.0 D between two consecutive refraction measurements
Time frame: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the percentage of subjects who experience different visual disturbances, by means of questionnaire
Time frame: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the occurrence of the different visual disturbances by means of questionnaire
Time frame: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the severity of the different visual disturbances by means of questionnaire
Time frame: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the bothersomeness of the different visual disturbances by means of questionnaire
Time frame: 3 years
Evaluation of visual disturbances using a validated questionnaire
Assessing the time of onset of visual disturbances by means of questionnaire
Time frame: 3 years
Satisfaction questionnaire
* Percentage of subjects that is satisfied with the overall procedure * Percentage of subjects that is satisfied with uncorrected near vision * Percentage of subjects that is satisfied with uncorrected intermediate vision * Percentage of subjects that is satisfied with uncorrected distance vision
Time frame: 3 years
Endothelial cell density
Comparison of the preoperative and postoperative endothelial cell density
Time frame: 3 years
Endothelial cell density
Endothelial cell loss over time
Time frame: 3 years
Endothelial cell density
Additionally, a comparison between the scientific literature reported naturally occurring endothelial cell loss over time (approx. 0.6% per year; Bourne et al., 1997) and the study observed cell loss will be performed
Time frame: 3 years
Adverse event (AEs) / complication rates
* Cumulative numbers of adverse events, e.g. cystoid macular edema (CME), hypopyon, endophthalmitis, lens dislocation, pupillary block, retinal detachment, necessary secondary surgical interventions * Cumulative numbers of adverse events persistently present, e.g. corneal stroma edema, cystoid macular edema, iritis, raised intraocular pressure (IOP) requiring treatment, lens deposits * The occurrence of adverse events will be compared to and should not exceed the reference safety and performance endpoint (SPE) rates as defined by ISO 11979-7:2018, Annex E, table E.1
Time frame: 3 years