Intra and Postoperative Outcomes With 3 Injectors

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02466256

Enrollment

120

Registered

2015-06-09

Start date

2013-12-31

Completion date

2014-06-30

Last updated

2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Intraocular lens implantation

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.

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

Interventions

PROCEDUREIntraocular lens implantation

Intraocular lens implantation

DEVICEAutosert Injector

Motorised injection device for intraocular lens implantation

DEVICERoyale Injector

Manual, plunger type injection device for intraocular lens implantation

DEVICEMonarch III Injector

Manual, screw type injection device for intraocular lens implantation

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incision enlargement in mm	1 minute after surgery

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026