Intra and Postoperative Outcomes With 3 Injectors

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Intraocular lens implantation; Device: Monarch III Injector; Device: Autosert Injector; Device: Royale Injector

• Registration Number: NCT02466256
• Lead Sponsor: Iladevi Cataract and IOL Research Center

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

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-08
• Last Update Submitted: 2015-06-08
• Study First Posted: 2015-06-09
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Royale Group	Intraocular lens implantation	Procedure / Surgery : Intraocular lens implantation with Royale Injector
Autosert Group	Intraocular lens implantation	Procedure / Surgery : Intraocular lens implantation with Autosert injector
Autosert Group	Autosert Injector	Procedure / Surgery : Intraocular lens implantation with Autosert injector
Royale Group	Royale Injector	Procedure / Surgery : Intraocular lens implantation with Royale Injector
Monarch III Injector	Monarch III Injector	Procedure / Surgery : Intraocular lens implantation with Monarch III group

Primary Outcome Measures

Name	Time	Method
Incision enlargement in mm	1 minute after surgery

Secondary Outcome Measures

Name	Time	Method
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