Glistenings and PCO Evaluation for the Envista MX60

• Sponsor: Democritus University of Thrace (Other)
• Overall Status: Completed
• CT.gov ID: NCT02698943
• Collaborator: (none)
• Enrollment: 60
• Duration (Months): 5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Phacoemulsification

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Glistenings and Posterior Capsule Opacification Following Envista MX60 Intraocular Lens Implantation
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Study Group Participants who underwent phacoemulsification surgery and implantation of the Envista MX-60 IOL	Procedure: Phacoemulsification; Phacoemulsification for cataract extraction with Envista MX-60 implantation

Outcome Measures

Primary Outcome Measures

1. Glistenings [1 year]

   Evaluation of glistenings using Scheimpflug analysis

2. Posterior capsule Opacification (PCO) [1 year]

   Evaluation of PCO using EPCO software

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Democritus University of Thrace

Investigators

• Study Chair: Georgios Labiris, MD, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Georgios Labiris, Assistant Professor, Democritus University of Thrace
• ClinicalTrials.gov Identifier: NCT02698943
• Other Study ID Numbers: 320/2-3-2016
• First Posted: Mar 4, 2016
• Last Update Posted: Mar 4, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Georgios Labiris, Assistant Professor, Democritus University of Thrace: cataract; intraocular lens; posterior capsule opacification; glistening; ENVISTA
• Additional relevant MeSH terms: Cataract; Capsule Opacification

Study Results

No Results Posted as of Mar 4, 2016