Clinical trial NCT02838004: Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
Official title: An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Presbyopia
Keywords: Refractive lens exchange (RLE) or cataract surgery
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2016-07-20
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.

Detailed description: To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries

Eligibility criteria: Inclusion Criteria:

* Any gender and age above 18 years.
* Refractive lens exchange (RLE) or cataract surgery.
* Healthy corneas, not treated surgically.
* Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).
* Patients request to receive the IOL MINI WELL READY implant

Exclusion Criteria:

* Previous corneal surgery (i.e. pterygium, refractive surgery).
* Eye diseases determining a probable postoperative visual acuity \< 20/40.
* Pseudoexfoliation.
* Abnormal pupil size and position.
* Use of contact lens 30 days before the preoperative visit.
* Corneal warpage.
* Predicted postoperative corneal astigmatism higher than 1 D.

Primary outcomes:
measure: UDVA (Uncorrected Distance Visual Acuity)
timeFrame: 30 days
Secondary outcomes:
measure: Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).
timeFrame: 4 months
Other outcomes:
measure: Visual Acuity Evaluation
timeFrame: 4 months
measure: Visual Acuity Evaluation
timeFrame: 4 months
measure: Visual Acuity Evaluation
timeFrame: 4 months
measure: Visual Acuity Evaluation
timeFrame: 4 months
measure: Visual Acuity Evaluation
timeFrame: 4 months
measure: Visual Acuity Evaluation
timeFrame: 4 months
measure: Halos and Glare evaluation
timeFrame: 4 months
measure: Contrast sensitivity
timeFrame: 4 months
measure: Reading Performance
timeFrame: 4 months
measure: Defocus Curve
timeFrame: 4 months
Locations:
city: Heidelberg
country: Germany
facility: Prof.Dr. Gerd U. Auffarth
Study officials:
affiliation: RUPRECHT KARLS UNIVERSITATS AUGENKLINIK HEIDELBERG
name: GERD U. AUFFARTH, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang T, Jiang J, Zhou Y, Zhao GQ, Li H, Zhao SY. Cataract surgery in aged patients: phacoemulsification or small-incision extracapsular cataract surgery. Int J Ophthalmol. 2011;4(5):513-8. doi: 10.3980/j.issn.2222-3959.2011.05.11. Epub 2011 Oct 18.
citation: Packer M, Fine IH, Hoffman RS. Aspheric intraocular lens selection: the evolution of refractive cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):1-4. doi: 10.1097/ICU.0b013e3282f2d791. No abstract available.
citation: Kohnen T, Klaproth OK, Buhren J. Effect of intraocular lens asphericity on quality of vision after cataract removal: an intraindividual comparison. Ophthalmology. 2009 Sep;116(9):1697-706. doi: 10.1016/j.ophtha.2009.03.052. Epub 2009 Jul 29.
citation: Lehmann R, Waycaster C, Hileman K. A comparison of patient-reported outcomes from an apodized diffractive intraocular lens and a conventional monofocal intraocular lens. Curr Med Res Opin. 2006 Dec;22(12):2591-602. doi: 10.1185/030079906X158039.
citation: Leyland M, Zinicola E. Multifocal versus monofocal intraocular lenses in cataract surgery: a systematic review. Ophthalmology. 2003 Sep;110(9):1789-98. doi: 10.1016/S0161-6420(03)00722-X.
citation: Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. doi: 10.1097/00055735-200002000-00004.
citation: Munoz G, Albarran-Diego C, Ferrer-Blasco T, Sakla HF, Garcia-Lazaro S. Visual function after bilateral implantation of a new zonal refractive aspheric multifocal intraocular lens. J Cataract Refract Surg. 2011 Nov;37(11):2043-52. doi: 10.1016/j.jcrs.2011.05.045.
citation: Ucakhan OO, Ozkan M, Kanpolat A. Anterior chamber parameters measured by the Pentacam CES after uneventful phacoemulsification in normotensive eyes. Acta Ophthalmol. 2009 Aug;87(5):544-8. doi: 10.1111/j.1755-3768.2008.01305.x. Epub 2008 Sep 11.
citation: Savini G, Olsen T, Carbonara C, Pazzaglia S, Barboni P, Carbonelli M, Hoffer KJ. Anterior chamber depth measurement in pseudophakic eyes: a comparison of Pentacam and ultrasound. J Refract Surg. 2010 May;26(5):341-7. doi: 10.3928/1081597X-20090617-02. Epub 2010 May 19.
citation: Attia MS, Khoramnia R, Auffarth GU, Kirchner M, Holzer MP. Near and intermediate visual and reading performance of patients with a multifocal apodized diffractive intraocular lens using an electronic reading desk. J Cataract Refract Surg. 2016 Apr;42(4):582-90. doi: 10.1016/j.jcrs.2015.11.047.
citation: Maxwell WA, Cionni RJ, Lehmann RP, Modi SS. Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study. J Cataract Refract Surg. 2009 Dec;35(12):2054-61. doi: 10.1016/j.jcrs.2009.06.041.