Glistenings and PCO Evaluation for the Envista MX60

• ClinicalTrials.gov Identifier: NCT02698943
• Recruitment Status: Completed
• First Posted: March 4, 2016
• Last Update Posted: March 4, 2016
• Sponsor: Democritus University of Thrace
• 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

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

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