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

NCT04940793 | Completed

• 1 other identifier: Ribeiro - POD FT
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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 independence will be investigated. The follow-up period is 3 months after which vision and refraction should have stabilized.

Conditions

Cataract

Keywords

Trifocal; Toric; Hydrophilic

Outcome Measures

Primary Outcomes (2)

• Visual performance

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

  3 Months

• Refractive predictability

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

  3 Months

Secondary Outcomes (5)

• Visual performance : predicted and achieved

  3 Months

• Visual performance at near, intermediate and far distance

  3 Months

• Refractive predictability: photic phenomena

  3 Months

• Refractive predictability: rotational stability

  3 Months

• Refractive predictability: spectacle independence

  3 Months

Study Arms (1)

Group 1

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

Device: POD FT

Interventions

POD FT DEVICE

Cataract surgery

Group 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

Study Sites (1)

Hospital da Luz

Lisbon, Portugal

Location

Related Publications (13)

• 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.

  PMID: 23522584 RESULT

• 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.

  PMID: 23332253 RESULT

• 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.

  PMID: 23688874 RESULT

• 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.

  PMID: 24124348 RESULT

• 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.

  PMID: 23332118 RESULT

• 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.

  PMID: 22969289 RESULT

• 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.

  PMID: 22425363 RESULT

• 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.

  PMID: 21940140 RESULT

• 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.

  PMID: 24075158 RESULT

• 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.

  PMID: 24355720 RESULT

• 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.

  PMID: 23680631 RESULT

• 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.

  PMID: 24203808 RESULT

• 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.

  PMID: 23352708 RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Filomena Ribeiro, MD, PhD, FEBO

  Hospital da Luz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 28, 2021
• Study Start: July 18, 2017
• Primary Completion: January 23, 2019
• Study Completion: January 23, 2019
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)