Posterior Capsule Opacification After Lens Capsule Polishing
Evaluation of Intraoperative Capsular Polishing on Lens Epithelial Cells and the Development of Posterior Capsule Opacification
1 other identifier
interventional
40
1 country
1
Brief Summary
Investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2019
CompletedFirst Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedMarch 16, 2020
March 1, 2020
1.2 years
February 26, 2019
March 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison between eye with capsular polishing and eye without capsular polishing concerning generation of posterior capsule opacification (PCO) in the same patient
Posterior capsule opacification will be graded using a score from 0 (clear capsule) to 10 (very severe PCO)
6 months
Secondary Outcomes (1)
Difference in the number of cells in the anterior chamber between the eye with capsular polishing and the eye without capsular polishing in the same patient
6 months
Study Arms (2)
Non capsular polishing
SHAM COMPARATORNo capsular polishing taking place during cataract surgery
Capsular polishing
ACTIVE COMPARATORCapsular polishing taking place during cataract surgery
Interventions
Capsular polishing taking place during cataract surgery
No capsular polishing taking place during cataract surgery
Eligibility Criteria
You may qualify if:
- Age-related cataract.
- Patients in the age group of 21 years and above.
- Patients with uncomplicated cataract.
- Patients without any relevant systemic or ocular morbidity.
- Patients with well dilating pupils.
- Written informed consent prior to any study specific action.
You may not qualify if:
- Patients with complicated cataract.
- Patients having corneal pathology.
- Patients with any form of ocular inflammation.
- Patients with glaucoma, retinal pathologies.
- Patients with traumatic cataracts, subluxated and dislocated lens, prior h/o ocular surgery, pseudoexfoliation.
- Any intraoperative complications like posterior capsule rupture.
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140, Austria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 26, 2019
First Posted
February 28, 2019
Study Start
February 13, 2019
Primary Completion
May 1, 2020
Study Completion
February 1, 2021
Last Updated
March 16, 2020
Record last verified: 2020-03