Clinical trial NCT04801992: Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant
Official title: Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Cataract surgery
Extended Depth-of-Focus (EDOF)
Intraocular Lens (IOL)
Presbyiopa correction
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2021-03-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects affected by cataract that fulfill eligibility criteria

Brief summary: The study objective is to evaluate the visual performance of MINI WELL Ready at 24 months following the second eye implant. The objectives of safety are to evaluate the rate of Secondary Surgical Interventions related to the optical properties of the IOL for first and second operative eye separately at 24 months and the rate of visual disturbances and distortions as reported by the subjects as detected by using the Halo \& Glare Simulator.

Detailed description: The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)

Eligibility criteria: Inclusion Criteria:

• Previous enrolment in the PSM8 study in the period from March, 1st 2014 to March, 31st 2016 with the following:

* Any gender and age above 18 years.
* Cataract or Refractive Lens Exchange (RLE) surgery; will be included patients submitted to conventional phacoemulsification as to femtolaser procedure; no specification regarding corneal incision size and position.
* Symmetrical preoperative keratometric astigmatism \< 1.00 D.
* Healthy corneas, not surgically treated

Exclusion Criteria:

* Previous corneal surgery (i.e. pterygium, refractive surgery).
* Eye diseases with visual acuity \< 20/32.
* Pseudoexfoliation.
* Abnormal pupil size and position.
* Use of contact lens 30 days before the preoperative visit.
* Corneal warpage.

Primary outcomes:
measure: Subjective Refraction
timeFrame: 26 months
measure: Binocular Defocus Curve
timeFrame: 26 months
measure: UDVA
timeFrame: 26 months
measure: CDVA
timeFrame: 26 months
measure: UIVA at 100 cm
timeFrame: 26 months
measure: DCIVA at 100 cm
timeFrame: 26 months
measure: UIVA at 60 cm
timeFrame: 26 months
measure: DCIVA at 60 cm
timeFrame: 26 months
measure: UNVA
timeFrame: 26 months
measure: DCNVA
timeFrame: 26 months
measure: Contrast Sensitivity
timeFrame: 26 months
measure: Reading Performance
timeFrame: 26 months
measure: VR-11R
timeFrame: 26 months
Secondary outcomes:
measure: Postoperative Complications Rate of postoperative complication
timeFrame: 26 months
measure: Subjective Posterior Capsule Opacification
timeFrame: 20-26 months
measure: Posterior Capsulotomy
timeFrame: 26 months
measure: Adverse Events including SSIs
timeFrame: 26 months
measure: Device Deficiencies
timeFrame: 26 months
measure: Photic Phenomena Assessment
timeFrame: 26 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: U.O. Oftalmologia I Dipartimento di Scienze Mediche di Base, Neuroscienze e Organi di Senso Università degli Studi di Bari "Aldo Moro"
Study officials:
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: Becker KA, Martin M, Rabsilber TM, Entz BB, Reuland AJ, Auffarth GU. Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study. Br J Ophthalmol. 2006 Aug;90(8):971-4. doi: 10.1136/bjo.2006.092437. Epub 2006 May 10.
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: Blaylock JF, Si Z, Vickers C. Visual and refractive status at different focal distances after implantation of the ReSTOR multifocal intraocular lens. J Cataract Refract Surg. 2006 Sep;32(9):1464-73. doi: 10.1016/j.jcrs.2006.04.011.