AzTrials
AzTrials

CataractNCT04801992

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

An observational study of Cataract, run by SIFI SpA at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract
What is being tested?
MINI WELL Ready (SIFI SpA, Italy)
Type of treatment
Medical device
How many people
23 participants
Where
1 siteItaly
Study dates
26 Oct 2020to 19 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Subjects affected by cataract that fulfill eligibility criteria

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Bari, 70121

Other trials in Italy

About this study

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

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.

Read the detailed description

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

Conditions
Cataract
Being tested
MINI WELL Ready (SIFI SpA, Italy)
Keywords
Cataract surgery, Extended Depth-of-Focus (EDOF), Intraocular Lens (IOL), Presbyiopa correction
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04801992
Study groupRoleWhat they receive
MINI WELL Ready (SIFI SpA, Italy)Extended depth of focus intraocular lens implantation
Receives: Device: MINI WELL Ready (SIFI SpA, Italy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective Refraction

    Measured: 26 months

  2. Binocular Defocus Curve

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

    Measured: 26 months

  3. UDVA

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

    Measured: 26 months

  4. CDVA

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

    Measured: 26 months

  5. UIVA at 100 cm

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

    Measured: 26 months

  6. DCIVA at 100 cm

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

    Measured: 26 months

  7. UIVA at 60 cm

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

    Measured: 26 months

  8. DCIVA at 60 cm

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

    Measured: 26 months

  9. UNVA

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

    Measured: 26 months

  10. DCNVA

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

    Measured: 26 months

  11. Contrast Sensitivity

    Binocular Contrast Sensitivity with correction for distance

    Measured: 26 months

  12. Reading Performance

    Binocular Reading Performance with and without correction for distance

    Measured: 26 months

  13. VR-11R

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

    Measured: 26 months

Secondary outcomes (6)

  1. Postoperative Complications Rate of postoperative complication

    Measured: 26 months

  2. Subjective Posterior Capsule Opacification

    Subjective assessment through slit lamp

    Measured: 20-26 months

  3. Posterior Capsulotomy

    Measured: 26 months

  4. Adverse Events including SSIs

    Measured: 26 months

  5. Device Deficiencies

    Descriptive assessment

    Measured: 26 months

  6. Photic Phenomena Assessment

    Using the Halo and Glare Simulator software

    Measured: 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2021
  2. Study start26 Oct 2020
  3. Primary completion19 Nov 2020
  4. Study completion19 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04801992
Sponsor's protocol ID
PSM8 Sub-study
Status last verified
Mar 2021
First submitted
15 Mar 2021
Last updated
22 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22553713

  • 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.

    PubMed 18090888

  • 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.

    PubMed 19643497

  • 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.

    PubMed 16687454

  • 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.

    PubMed 17166341

  • 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.

    PubMed 13129879

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

    PubMed 10724823

  • 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.

    PubMed 16931257

  • Sborgia A, Curatolo MC, Barattini DF, Niro A, Barattini L, Sborgia G. Two-Year Follow-Up of the MINI WELL Non-Diffractive Extended Depth-of-Focus Intraocular Lens: A Retrospective Observational Study. Clin Ophthalmol. 2026 Jun 24;20:602800. doi: 10.2147/OPTH.S602800. eCollection 2026.

    PubMed 42376480

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by SIFI SpA at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Refraction (time frame: 26 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04801992, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in