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

Cataract Clinical Trial

— RibeiroPODFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940793
• Other study ID #: Ribeiro - POD FT
• Status: Completed
• Start date: July 18, 2017
• Est. completion date: January 23, 2019

Study information

• Verified date: June 2021
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 23, 2019
• Est. primary completion date: January 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• POD FT
Cataract surgery

Locations

Country	Name	City	State
Portugal	Hospital da Luz	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

Portugal, 

References & Publications (13)

Alfonso JF, Knorz M, Fernandez-Vega L, Rincón 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 — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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. Review. — View Citation

Ferreira TB, Marques EF, Rodrigues A, Montés-Micó 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. — View Citation

Knorz MC, Rincón JL, Suarez E, Alfonso JF, Fernández-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( — View Citation

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 — View Citation

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. Ep — View Citation

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. R — View Citation

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 S — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual performance	The purpose of this study is to investigate the visual performance of the diffractive toric Finevision POD FT IOL.	3 Months
Primary	Refractive predictability	The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL.	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months