Intra and Postoperative Outcomes With 3 Injectors

June 8, 2015 updated by: Abhay R. Vasavada, Iladevi Cataract and IOL Research Center

Comparison of Intraoperative Performance and Incision Morphology Using Three Injector Devices : Randomized, Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this randomized, clinical trial, three types of injectors were compared :

  1. Manual, screw type injector (Monarch III)
  2. Manual, plunger type injector (Royale, ASICO)
  3. Motorized injector (Autosert, Alcon)

Having performed a phacoemulsification through 2.2mm incision, IOL implantation was performed using a D cartridge and one of three injectors which was decided in a randomized fashion.

The investigators evaluated incision enlargement at following points : at the end of phacoemulsification, and then, at the end of IOL implantation The investigators also looked at trypan blue ingress into the anterior chamber from the ocular surface. At 1 day, 1 week, and 1 month after surgery anterior segment OCT morphology was also studied.

further, the surgeon was asked to subjectively grade the ease of implantation with each injector

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Autosert Group
Procedure / Surgery : Intraocular lens implantation with Autosert injector
Procedure: Intraocular lens implantation
Intraocular lens implantation
Device: Autosert Injector
Motorised injection device for intraocular lens implantation
Placebo Comparator: Royale Group
Procedure / Surgery : Intraocular lens implantation with Royale Injector
Procedure: Intraocular lens implantation
Intraocular lens implantation
Device: Royale Injector
Manual, plunger type injection device for intraocular lens implantation
Placebo Comparator: Monarch III Injector
Procedure / Surgery : Intraocular lens implantation with Monarch III group
Device: Monarch III Injector
Manual, screw type injection device for intraocular lens implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incision enlargement in mm
Time Frame: 1 minute after surgery
1 minute after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Trypan Blue ingress into the anterior chamber in log units
Time Frame: 1 minute after surgery
1 minute after surgery
Incision morphology - qualitative
Time Frame: 1 day, 1 week and 1 month after surgery
1 day, 1 week and 1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iladevi Cataract and IOL Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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