Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens

Cataract Clinical Trial

— PSM15  

Official title:

An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838004
• Other study ID #: PSM15
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: January 2020
• Source: SIFI SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.

Description:

To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any gender and age above 18 years.

• Refractive lens exchange (RLE) or cataract surgery.

• Healthy corneas, not treated surgically.

• Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).

• Patients request to receive the IOL MINI WELL READY implant

Exclusion Criteria:

• Previous corneal surgery (i.e. pterygium, refractive surgery).

• Eye diseases determining a probable postoperative visual acuity < 20/40.

• Pseudoexfoliation.

• Abnormal pupil size and position.

• Use of contact lens 30 days before the preoperative visit.

• Corneal warpage.

• Predicted postoperative corneal astigmatism higher than 1 D.

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• IOL MINI WELL READY
IOL MINI WELL READY

Locations

Country	Name	City	State
Germany	Prof.Dr. Gerd U. Auffarth	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
SIFI SpA	Opera CRO, a TIGERMED Group Company

Country where clinical trial is conducted

Germany, 

References & Publications (11)

Attia MS, Khoramnia R, Auffarth GU, Kirchner M, Holzer MP. Near and intermediate visual and reading performance of patients with a multifocal apodized diffractive intraocular lens using an electronic reading desk. J Cataract Refract Surg. 2016 Apr;42(4):582-90. doi: 10.1016/j.jcrs.2015.11.047. — View Citation

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. — View Citation

Kohnen T, Klaproth OK, Bühren 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. — View Citation

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. — View Citation

Leyland M, Zinicola E. Multifocal versus monofocal intraocular lenses in cataract surgery: a systematic review. Ophthalmology. 2003 Sep;110(9):1789-98. Review. — View Citation

Maxwell WA, Cionni RJ, Lehmann RP, Modi SS. Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study. J Cataract Refract Surg. 2009 Dec;35(12):2054-61. doi: 10.1016/j.jcrs.2009.06.041. — View Citation

Muñoz G, Albarrán-Diego C, Ferrer-Blasco T, Sakla HF, García-Lázaro S. Visual function after bilateral implantation of a new zonal refractive aspheric multifocal intraocular lens. J Cataract Refract Surg. 2011 Nov;37(11):2043-52. doi: 10.1016/j.jcrs.2011.05.045. — View Citation

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. — View Citation

Savini G, Olsen T, Carbonara C, Pazzaglia S, Barboni P, Carbonelli M, Hoffer KJ. Anterior chamber depth measurement in pseudophakic eyes: a comparison of Pentacam and ultrasound. J Refract Surg. 2010 May;26(5):341-7. doi: 10.3928/1081597X-20090617-02. Epub 2010 May 19. — View Citation

Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. Review. — View Citation

Uçakhan OO, Ozkan M, Kanpolat A. Anterior chamber parameters measured by the Pentacam CES after uneventful phacoemulsification in normotensive eyes. Acta Ophthalmol. 2009 Aug;87(5):544-8. doi: 10.1111/j.1755-3768.2008.01305.x. Epub 2008 Sep 11. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Acuity Evaluation	Corrected Distance Visual Acuity (CDVA)	4 months
Other	Visual Acuity Evaluation	Uncorrected Near Visual Acuity (UNVA)	4 months
Other	Visual Acuity Evaluation	Distance-Corrected Near Visual Acuity (DCNVA)	4 months
Other	Visual Acuity Evaluation	Corrected Near Visual Acuity (CNVA)	4 months
Other	Visual Acuity Evaluation	Uncorrected Intermediate Visual Acuity (UIVA)	4 months
Other	Visual Acuity Evaluation	Distance-Corrected Intermediate Visual Acuity (DCIVA)	4 months
Other	Halos and Glare evaluation	Onset of halos Onset of glare during night vision	4 months
Other	Contrast sensitivity	Contrast sensitivity, at 3 meters, under photopic conditions and with the correction for distance, using YANG SMART (SIFI Medtech), with sine wave gradings (''vistech")	4 months
Other	Reading Performance	Reading Performance tested with Radner Reading Chart - Precision Vision: The test will be performed from the largest to the smallest size of letters in two sessions: Binocular, without the correction for distance, at 40 cm; Binocular, with the correction for distance, at 40 cm	4 months
Other	Defocus Curve	Binocular defocus curves with step of 0.5 D (from +2.0 to -5.0 D) under photopic conditions.	4 months
Primary	UDVA (Uncorrected Distance Visual Acuity)	Visual acuity mesurement	30 days
Secondary	Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).	Safety assessment	4 months