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Glistenings and PCO Evaluation for the Envista MX60

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ClinicalTrials.gov Identifier: NCT02698943
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace

Tracking Information
First Submitted Date March 2, 2016
First Posted Date March 4, 2016
Last Update Posted Date March 4, 2016
Study Start Date September 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2016)
  • Glistenings [ Time Frame: 1 year ]
    Evaluation of glistenings using Scheimpflug analysis
  • Posterior capsule Opacification (PCO) [ Time Frame: 1 year ]
    Evaluation of PCO using EPCO software
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Glistenings and PCO Evaluation for the Envista MX60
Official Title Evaluation of Glistenings and Posterior Capsule Opacification Following Envista MX60 Intraocular Lens Implantation
Brief Summary Posterior capsule opacification (PCO) and glistenings development is among the primary reasons for sub-optimal visual capacity following cataract extraction surgery. Primary objective of this study is to evaluate the incidence of PCO and glistenings of the popular envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who underwent phacoemulsification at least 1 year prior to their enrollment at the study
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with senile cataract
Condition Cataract
Intervention Procedure: Phacoemulsification
Phacoemulsification for cataract extraction with Envista MX-60 implantation
Study Groups/Cohorts Study Group
Participants who underwent phacoemulsification surgery and implantation of the Envista MX-60 IOL
Intervention: Procedure: Phacoemulsification
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 2, 2016)
60
Original Actual Enrollment Same as current
Actual Study Completion Date February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

Endothelial cell count less than 1900, glaucoma, IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes or autoimmune diseases

Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02698943
Other Study ID Numbers 320/2-3-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Georgios Labiris, Democritus University of Thrace
Study Sponsor Democritus University of Thrace
Collaborators Not Provided
Investigators
Study Chair: Georgios Labiris, MD, PhD Assistant Professor
PRS Account Democritus University of Thrace
Verification Date March 2016