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Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens (PSM15)

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ClinicalTrials.gov Identifier: NCT02838004
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Opera Contract Research Organization SRL
Information provided by (Responsible Party):
SIFI MedTech Srl

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

Condition or disease Intervention/treatment Phase
Vision Disorders Device: IOL MINI WELL READY Not Applicable

Detailed 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : May 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Heidelberg University
IOL MINI WELL READY implant
Device: IOL MINI WELL READY
IOL MINI WELL READY implant




Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Serious Adverse Device Effect / Serious Adverse Event [ Time Frame: 30 days ]

Other Outcome Measures:
  1. Onset of glare during night vision (questionnaire) [ Time Frame: 30 days ]
  2. Contrast sensitivity with and without glare (questionnaire) [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838004


Locations
Germany
Prof.Dr. Gerd U. Auffarth
Heidelberg, Germany
Romania
Opera Contract Research Organization Srl
Timisoara, Timis, Romania, 300209
Sponsors and Collaborators
SIFI MedTech Srl
Opera Contract Research Organization SRL
Investigators
Principal Investigator: Auffarth Gerd U., Prof.dr. Universitäts-Augenklinik, Heidelberg

Publications:

Responsible Party: SIFI MedTech Srl
ClinicalTrials.gov Identifier: NCT02838004     History of Changes
Other Study ID Numbers: PSM15
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by SIFI MedTech Srl:
Refractive lens exchange (RLE) or cataract surgery

Additional relevant MeSH terms:
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms