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CataractRibeiroPODFTNCT04940793

Visual and Refractive Outcomes of a New Diffractive Trifocal Toric Intraocular Lens

An observational study of Cataract, run by Beaver-Visitec International, Inc. at 1 site in Portugal.

Completed

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

Official record
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Trial summary

The purpose of this study is to investigate the visual performance and refractive predictability with the diffractive toric Finevision POD FT IOL. Predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as photic phenomena, rotational stability and spectacle… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract
What is being tested?
POD FT
Type of treatment
Medical device
How many people
46 participants
Where
1 sitePortugal
Study dates
18 Jul 2017to 23 Jan 2019
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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients indicated for cataract surgery who are candidates for a trifocal IOL implantation and have corneal astigmatism over 1.00 D will be selected for inclusion by the investigators. Only patients with binocular implantation of a Finevision IOL will be included (either a POD FT in both eyes or a POD FT in the study eye and a POD F in the contralateral eye).

Who may be able to join

  • age 21 and older
  • bilateral implantation of a Finevision trifocal diffractive IOL (either a POD FT in both eyes or a POD FT in the study eye and a POD F in the contralateral eye)
  • bilateral cataract surgery with grade 1-4 cataract
  • regular corneal astigmatism of 1.00 D or more before surgery in the study eye
  • previous written informed consent to surgery. Written informed consent to participation in the study and data protection

Who cannot join

  • relevant concomitant ophthalmic diseases (such as pseudoexfoliation, glaucoma, traumatic cataract and other co-morbidity that could affect capsular bag stability (e.g. Marfan syndrome)
  • irregular corneal astigmatism, any abnormality in corneal topography
  • systemic disease with impact on visual outcome
  • disability to understand and/or fill in patient questionnaires
  • history of other relevant previous ocular surgery (such as corneal surgery, glaucoma surgery, vitreoretinal surgery) which might affect capsular stability or visual outcomes
  • expected residual cylinder ≥ 0.50 D

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Hospital da Luz

    Lisbon

Other trials in Portugal

About this study

The purpose of this study is to investigate the visual performance and refractive predictability with the diffractive toric Finevision POD FT IOL. Predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as photic phenomena, rotational stability and spectacle independence will be investigated. The follow-up period is 3 months after which vision and refraction should have stabilized.

Read the detailed description

This prospective study was performed to investigate the visual performance and refractive predictability with the diffractive toric Finevision POD FT IOL (PhyslOL, Belgium). Predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as rotational stability have been analyzed. The follow-up period was 6 months. All IOL implantations were performed by the investigators Dr. Filomena Ribeiro and Dr. Tiago B Ferreira (Hospital da Luz, Lisboa, Portugal). The study population consists of patients undergoing routine cataract surgery. The study patients underwent binocular implantation of Finevision IOLs depending on the preoperative amount of corneal astigmatism (either a toric POD FT IOL in both eyes or a POD FT in the study eye and a non-toric POD F IOL in the contralateral eye).

Conditions
Cataract
Being tested
POD FT
Keywords
Trifocal, Toric, Hydrophilic
Medical subject headings
Cataract

What participants receive

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

  • POD FTDevice

    Cataract surgery

Study groups in NCT04940793
Study groupRoleWhat they receive
Group 1Patients indicated for cataract surgery who are candidates for a trifocal IOL implantation and have corneal astigmatism over 1.00 D will be selected for inclusion by the investigators
Receives: Device: POD FT

What is being measured

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

  1. Visual performance

    The purpose of this study is to investigate the visual performance of the diffractive toric Finevision POD FT IOL.

    Measured: 3 Months

  2. Refractive predictability

    The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL.

    Measured: 3 Months

Secondary outcomes (5)

  1. Visual performance : predicted and achieved

    The purpose of this study is to investigate the visual performance of the diffractive toric Finevision POD FT IOL. Predicted and achieved visual outcomes will be investigated.

    Measured: 3 Months

  2. Visual performance at near, intermediate and far distance

    The purpose of this study is to investigate the visual performance of the diffractive toric Finevision POD FT IOL. Visual performance at near, intermediate and far distance will be investigated.

    Measured: 3 Months

  3. Refractive predictability: photic phenomena

    The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL. The photic phenomena will be investigated.

    Measured: 3 Months

  4. Refractive predictability: rotational stability

    The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL. The rotational stability will be investigated.

    Measured: 3 Months

  5. Refractive predictability: spectacle independence

    The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL. The spectacle independence will be investigated.

    Measured: 3 Months

Timeline

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

  1. First posted28 Jun 2021
  2. Study start18 Jul 2017
  3. Primary completion23 Jan 2019
  4. Study completion23 Jan 2019

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
Prospective
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04940793
Sponsor's protocol ID
Ribeiro - POD FT
Acronym
RibeiroPODFT
Status last verified
Jun 2021
First submitted
18 Jun 2021
Last updated
28 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Visser N, Bauer NJ, Nuijts RM. Toric intraocular lenses: historical overview, patient selection, IOL calculation, surgical techniques, clinical outcomes, and complications. J Cataract Refract Surg. 2013 Apr;39(4):624-37. doi: 10.1016/j.jcrs.2013.02.020.

    PubMed 23522584

  • de Vries NE, Nuijts RM. Multifocal intraocular lenses in cataract surgery: literature review of benefits and side effects. J Cataract Refract Surg. 2013 Feb;39(2):268-78. doi: 10.1016/j.jcrs.2012.12.002.

    PubMed 23332253

  • Wolffsohn JS, Jinabhai AN, Kingsnorth A, Sheppard AL, Naroo SA, Shah S, Buckhurst P, Hall LA, Young G. Exploring the optimum step size for defocus curves. J Cataract Refract Surg. 2013 Jun;39(6):873-80. doi: 10.1016/j.jcrs.2013.01.031.

    PubMed 23688874

  • Vryghem JC, Heireman S. Visual performance after the implantation of a new trifocal intraocular lens. Clin Ophthalmol. 2013;7:1957-65. doi: 10.2147/OPTH.S44415. Epub 2013 Oct 1.

    PubMed 24124348

  • Sheppard AL, Shah S, Bhatt U, Bhogal G, Wolffsohn JS. Visual outcomes and subjective experience after bilateral implantation of a new diffractive trifocal intraocular lens. J Cataract Refract Surg. 2013 Mar;39(3):343-9. doi: 10.1016/j.jcrs.2012.09.017. Epub 2013 Jan 16.

    PubMed 23332118

  • Cochener B, Vryghem J, Rozot P, Lesieur G, Heireman S, Blanckaert JA, Van Acker E, Ghekiere S. Visual and refractive outcomes after implantation of a fully diffractive trifocal lens. Clin Ophthalmol. 2012;6:1421-7. doi: 10.2147/OPTH.S32343. Epub 2012 Sep 3.

    PubMed 22969289

  • Roensch MA, Charton JW, Blomquist PH, Aggarwal NK, McCulley JP. Resident experience with toric and multifocal intraocular lenses in a public county hospital system. J Cataract Refract Surg. 2012 May;38(5):793-8. doi: 10.1016/j.jcrs.2011.11.043. Epub 2012 Mar 15.

    PubMed 22425363

  • Visser N, Nuijts RM, de Vries NE, Bauer NJ. Visual outcomes and patient satisfaction after cataract surgery with toric multifocal intraocular lens implantation. J Cataract Refract Surg. 2011 Nov;37(11):2034-42. doi: 10.1016/j.jcrs.2011.05.041. Epub 2011 Sep 22.

    PubMed 21940140

  • Bellucci R, Bauer NJ, Daya SM, Visser N, Santin G, Cargnoni M, Nuijts RM; Lisa Toric Study Group. Visual acuity and refraction with a diffractive multifocal toric intraocular lens. J Cataract Refract Surg. 2013 Oct;39(10):1507-18. doi: 10.1016/j.jcrs.2013.04.036.

    PubMed 24075158

  • Alfonso JF, Knorz M, Fernandez-Vega L, Rincon JL, Suarez E, Titke C, Kohnen T. Clinical outcomes after bilateral implantation of an apodized +3.0 D toric diffractive multifocal intraocular lens. J Cataract Refract Surg. 2014 Jan;40(1):51-9. doi: 10.1016/j.jcrs.2013.06.026.

    PubMed 24355720

  • Ferreira TB, Marques EF, Rodrigues A, Montes-Mico R. Visual and optical outcomes of a diffractive multifocal toric intraocular lens. J Cataract Refract Surg. 2013 Jul;39(7):1029-35. doi: 10.1016/j.jcrs.2013.02.037. Epub 2013 May 13.

    PubMed 23680631

  • Knorz MC, Rincon JL, Suarez E, Alfonso JF, Fernandez-Vega L, Titke C, Kohnen T, Tucker S. Subjective outcomes after bilateral implantation of an apodized diffractive +3.0 D multifocal toric IOL in a prospective clinical study. J Refract Surg. 2013 Nov;29(11):762-7. doi: 10.3928/1081597X-20131021-06.

    PubMed 24203808

  • Chassain C, Pagnoulle C, Gobin L, Rozema J. [Evaluation of a new intraocular lens platform: centration and rotational stability]. J Fr Ophtalmol. 2013 Apr;36(4):336-42. doi: 10.1016/j.jfo.2012.04.012. Epub 2013 Jan 24. French.

    PubMed 23352708

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by Beaver-Visitec International, Inc. at 1 site in Portugal.

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 28 Jun 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 Portugal. 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?

Visual performance (time frame: 3 Months). The study lists 2 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 NCT04940793, which also lists 13 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 28 Jun 2021.

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