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Completed

NCT Number: NCT04801992

Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Subjective Refraction

    Time frame: 26 months

  2. Binocular Defocus Curve

    Time frame: 26 months

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

  3. UDVA

    Time frame: 26 months

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

  4. CDVA

    Time frame: 26 months

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

  5. UIVA at 100 cm

    Time frame: 26 months

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

  6. DCIVA at 100 cm

    Time frame: 26 months

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

  7. UIVA at 60 cm

    Time frame: 26 months

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

  8. DCIVA at 60 cm

    Time frame: 26 months

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

  9. UNVA

    Time frame: 26 months

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

  10. DCNVA

    Time frame: 26 months

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

  11. Contrast Sensitivity

    Time frame: 26 months

    Binocular Contrast Sensitivity with correction for distance

  12. Reading Performance

    Time frame: 26 months

    Binocular Reading Performance with and without correction for distance

  13. VR-11R

    Time frame: 26 months

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

Secondary outcomes

  1. Postoperative Complications Rate of postoperative complication

    Time frame: 26 months

  2. Subjective Posterior Capsule Opacification

    Time frame: 20-26 months

    Subjective assessment through slit lamp

  3. Posterior Capsulotomy

    Time frame: 26 months

  4. Adverse Events including SSIs

    Time frame: 26 months

  5. Device Deficiencies

    Time frame: 26 months

    Descriptive assessment

  6. Photic Phenomena Assessment

    Time frame: 26 months

    Using the Halo and Glare Simulator software

Sponsors and collaborators

Lead sponsor

SIFI SpA

Industry

Collaborators

  • Opera CRO, a TIGERMED Group Company

Registry information

Official study title

Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 17, 2021
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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