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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04801992
• Other study ID #: PSM8 Sub-study
• Status: Completed
• Start date: October 26, 2020
• Est. completion date: November 19, 2020

Study information

• Verified date: March 2021
• Source: SIFI SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 the rate of visual disturbances and distortions as reported by the subjects as detected by using the Halo & Glare Simulator.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 19, 2020
• Est. primary completion date: November 19, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• MINI WELL Ready (SIFI SpA, Italy)
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.

Locations

Country	Name	City	State
Italy	U.O. Oftalmologia I Dipartimento di Scienze Mediche di Base, Neuroscienze e Organi di Senso Università degli Studi di Bari "Aldo Moro"	Bari

Sponsors (2)

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

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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):9 — View Citation

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. — 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

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Refraction		26 months
Primary	Binocular Defocus Curve	Binocular Defocus Curve (+2.0 D to -4.0 D in 0.5 D increments)	26 months
Primary	UDVA	Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m	26 months
Primary	CDVA	Monocular and Binocular Corrected Distance Visual Acuity (CDVA) at 4m	26 months
Primary	UIVA at 100 cm	Monocular and Binocular Uncorrected Intermediate Visual Acuity at 100 cm (100% and 10% contrast)	26 months
Primary	DCIVA at 100 cm	Monocular and Binocular Distance Corrected Intermediate Visual at 100 cm (100% and 10% contrast)	26 months
Primary	UIVA at 60 cm	Monocular and Binocular Uncorrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)	26 months
Primary	DCIVA at 60 cm	Monocular and Binocular Distance Corrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)	26 months
Primary	UNVA	Monocular and Binocular Uncorrected Near Visual Acuity at 40cm (100% contrast)	26 months
Primary	DCNVA	Monocular and Binocular Distance Corrected Near Visual Acuity at 40cm (100% contrast)	26 months
Primary	Contrast Sensitivity	Binocular Contrast Sensitivity with correction for distance	26 months
Primary	Reading Performance	Binocular Reading Performance with and without correction for distance	26 months
Primary	VR-11R	Visual Function -11R Questionnaire from 4 (without difficulties) to 0 (performance impossible due to difficulties)	26 months
Secondary	Postoperative Complications Rate of postoperative complication		26 months
Secondary	Subjective Posterior Capsule Opacification	Subjective assessment through slit lamp	20-26 months
Secondary	Posterior Capsulotomy		26 months
Secondary	Adverse Events including SSIs		26 months
Secondary	Device Deficiencies	Descriptive assessment	26 months
Secondary	Photic Phenomena Assessment	Using the Halo and Glare Simulator software	26 months