Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03297372|
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cataract Lens Opacities||Device: IOL implantation||Not Applicable|
The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading.
Follow up will be up to 24 months postoperative.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: IOL Implantation experimental
Implantation of Micropure 1.2.3. in one of the eyes of the study subject
Device: IOL implantation
Implantation of monofocal IOL Micropure 1.2.3
- monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions [ Time Frame: 6 months postoperative ]The primary study end point is to show statistically equal visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions compared to literature data on a monofocal hydrophobic IOL (Alcon - Acrysof SN60AT).
- Posterior capsule opacification (PCO) grading [ Time Frame: 2 years postoperative ]grade of the PCO determined by slitlamp
- Uncorrected Distance Visual acuity (UDVA) [ Time Frame: 6 months postoperative ]Monocular Uncorrected Distance Visual acuity (UDVA)
- Contrast Sensitivity [ Time Frame: 6 months postoperative ]Contrast Sensitivity under photopic and mesopic light conditions
- Glistening assessment [ Time Frame: 2 years postoperative ]Assessment of glistenings by slitlamp determination
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): NCT03297372
|Contact: Jochen Kandulla, PhD||+49 157 862 75 firstname.lastname@example.org|
|Contact: Sally Lamborelle||+32 4 361 45 email@example.com|
|Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico||Recruiting|
|Rome, Italy, 00184|
|Contact: Augusto Pocobelli, MD +39 6 77052950 firstname.lastname@example.org|
|Principal Investigator: Augusto Pocobelli, MD|
|Fondazione GB Bietti - IRCCS||Recruiting|
|Rome, Italy, 00198|
|Contact: Domenico Schiano, MD +39 6 85356727 email@example.com|
|Principal Investigator: Domenico Schiano, MD|
|Principal Investigator:||Domenico Schiano, MD||Fondazione GB Bietti - IRCCS|