NCT04801992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2020

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

24 days

First QC Date

March 15, 2021

Last Update Submit

March 17, 2021

Conditions

Cataract

Keywords

Cataract surgeryExtended Depth-of-Focus (EDOF)Intraocular Lens (IOL)Presbyiopa correction

Outcome Measures

Primary Outcomes (13)

  • Subjective Refraction

    26 months

  • Binocular Defocus Curve

    Binocular Defocus Curve (+2.0 D to -4.0 D in 0.5 D increments)

    26 months

  • UDVA

    Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m

    26 months

  • CDVA

    Monocular and Binocular Corrected Distance Visual Acuity (CDVA) at 4m

    26 months

  • UIVA at 100 cm

    Monocular and Binocular Uncorrected Intermediate Visual Acuity at 100 cm (100% and 10% contrast)

    26 months

  • DCIVA at 100 cm

    Monocular and Binocular Distance Corrected Intermediate Visual at 100 cm (100% and 10% contrast)

    26 months

  • UIVA at 60 cm

    Monocular and Binocular Uncorrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)

    26 months

  • DCIVA at 60 cm

    Monocular and Binocular Distance Corrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)

    26 months

  • UNVA

    Monocular and Binocular Uncorrected Near Visual Acuity at 40cm (100% contrast)

    26 months

  • DCNVA

    Monocular and Binocular Distance Corrected Near Visual Acuity at 40cm (100% contrast)

    26 months

  • Contrast Sensitivity

    Binocular Contrast Sensitivity with correction for distance

    26 months

  • Reading Performance

    Binocular Reading Performance with and without correction for distance

    26 months

  • VR-11R

    Visual Function -11R Questionnaire from 4 (without difficulties) to 0 (performance impossible due to difficulties)

    26 months

Secondary Outcomes (6)

  • Postoperative Complications Rate of postoperative complication

    26 months

  • Subjective Posterior Capsule Opacification

    20-26 months

  • Posterior Capsulotomy

    26 months

  • Adverse Events including SSIs

    26 months

  • Device Deficiencies

    26 months

  • +1 more secondary outcomes

Study Arms (1)

MINI WELL Ready (SIFI SpA, Italy)

Extended depth of focus intraocular lens implantation

Device: MINI WELL Ready (SIFI SpA, Italy)

Interventions

MINI WELL Ready (SIFI SpA, Italy)DEVICE

Implantation during cataract surgery of the progressive extended depth of focus intraocular lens for the posterior chamber to replace the crystalline lens in the correction of aphakia in adult patients.

MINI WELL Ready (SIFI SpA, Italy)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects affected by cataract that fulfill eligibility criteria

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.O. Oftalmologia I Dipartimento di Scienze Mediche di Base, Neuroscienze e Organi di Senso Università degli Studi di Bari "Aldo Moro"

Bari, 70121, Italy

Location

Related Publications (8)

  • 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.

    PMID: 22553713RESULT

  • 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.

    PMID: 18090888RESULT

  • 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.

    PMID: 19643497RESULT

  • 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.

    PMID: 16687454RESULT

  • 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.

    PMID: 17166341RESULT

  • 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.

    PMID: 13129879RESULT

  • Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. doi: 10.1097/00055735-200002000-00004.

    PMID: 10724823RESULT

  • 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.

    PMID: 16931257RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 17, 2021

Study Start

October 26, 2020

Primary Completion

November 19, 2020

Study Completion

November 19, 2020

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations

IT(1)