Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses
1 other identifier
observational
99
1 country
1
Brief Summary
The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2011
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
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 16, 2012
November 1, 2012
1.2 years
July 14, 2011
November 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intra operative complication
to asssess the incidence of cartridge related post operative complications occurring in the anterior chamber on day 1
post operative day 1
Study Arms (1)
single group
the intra ocular lenses will be loaded in the cartridge.
Interventions
IOL cartridge coated with polymer material may ensure smooth delivery of IOL during cataract surgery
Eligibility Criteria
Patient with senile cataract or Nuclear Sclerosis grade I and grade II and age between 40-60
You may qualify if:
- Age 40 to 60
- Senile cataract
- Nuclear Sclerosis grade I and grade II
You may not qualify if:
- Inherent zonular weakness
- Shallow anterior chamber
- PXF
- Traumatic cataract
- Uveitis and Complicated cataract
- Dense PSCC and PPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aurolablead
Study Sites (1)
Aravind Eye Hospital
Madurai, Tamil Nadu, 625020, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Haripriya Aravind, MBBS., MS.,
HOD of IOL & Cataract clinic, Aravind Eye Hospital, Madurai
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2011
First Posted
July 19, 2011
Study Start
July 1, 2011
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
November 16, 2012
Record last verified: 2012-11