Intra and Postoperative Outcomes With 3 Injectors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Autosert Group

Procedure / Surgery : Intraocular lens implantation with Autosert injector

Group Type PLACEBO_COMPARATOR

Intraocular lens implantation

Intervention Type PROCEDURE

Intraocular lens implantation

Autosert Injector

Intervention Type DEVICE

Motorised injection device for intraocular lens implantation

Royale Group

Procedure / Surgery : Intraocular lens implantation with Royale Injector

Group Type PLACEBO_COMPARATOR

Intraocular lens implantation

Intervention Type PROCEDURE

Intraocular lens implantation

Royale Injector

Intervention Type DEVICE

Manual, plunger type injection device for intraocular lens implantation

Monarch III Injector

Procedure / Surgery : Intraocular lens implantation with Monarch III group

Group Type PLACEBO_COMPARATOR

Monarch III Injector

Intervention Type DEVICE

Manual, screw type injection device for intraocular lens implantation

Interventions

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Intraocular lens implantation

Intervention Type PROCEDURE

Autosert Injector

Motorised injection device for intraocular lens implantation

Intervention Type DEVICE

Royale Injector

Manual, plunger type injection device for intraocular lens implantation

Intervention Type DEVICE

Monarch III Injector

Manual, screw type injection device for intraocular lens implantation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No