Intra and Postoperative Outcomes With 3 Injectors
Comparison of Intraoperative Performance and Incision Morphology Using Three Injector Devices : Randomized, Clinical Trial
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
This randomized clinical trial compares subjective performance during Intraocular lens (IOL) implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision using one of three injectors : Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector (Autosert). Further, the investigators also looked at incision integrity by comparing ingress of trypan blue from the ocular surface into the anterior chamber.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 9, 2015
CompletedJune 9, 2015
June 1, 2015
6 months
June 2, 2015
June 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incision enlargement in mm
1 minute after surgery
Secondary Outcomes (2)
Trypan Blue ingress into the anterior chamber in log units
1 minute after surgery
Incision morphology - qualitative
1 day, 1 week and 1 month after surgery
Study Arms (3)
Autosert Group
PLACEBO COMPARATORProcedure / Surgery : Intraocular lens implantation with Autosert injector
Royale Group
PLACEBO COMPARATORProcedure / Surgery : Intraocular lens implantation with Royale Injector
Monarch III Injector
PLACEBO COMPARATORProcedure / Surgery : Intraocular lens implantation with Monarch III group
Interventions
Manual, plunger type injection device for intraocular lens implantation
Manual, screw type injection device for intraocular lens implantation
Eligibility Criteria
You may qualify if:
- Patients undergoing phacoemulsification for age-related uncomplicated cataracts through a 2.2mm incision.
- Nuclear or corticonuclear of grade 2 to 4 according to the Lens Opacities Classification System (LOCS III)
You may not qualify if:
- Glaucoma,
- uveitis,
- shallow anterior chamber (depth \<2.1mm),
- prior ocular trauma or surgery,
- maximal pupillary dilatation \<6mm,
- high myopia (axial length \>25mm),
- posterior polar cataracts,
- dense cataracts, and
- an IOL power \<19.0 D or \>25.0 D
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
abhay r vasavada, ms, frcs
iladevi cataract & iol research centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.S., F.R.C.S (England)
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 9, 2015
Study Start
December 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 9, 2015
Record last verified: 2015-06