NCT02466256

Intra and Postoperative Outcomes With 3 Injectors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Iladevi Cataract and IOL Research Center · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cataract

Interventions

Type	Name	Description
PROCEDURE	Intraocular lens implantation	Intraocular lens implantation
DEVICE	Autosert Injector	Motorised injection device for intraocular lens implantation
DEVICE	Royale Injector	Manual, plunger type injection device for intraocular lens implantation
DEVICE	Monarch III Injector	Manual, screw type injection device for intraocular lens implantation

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2015-06-09
• Last updated: 2015-06-09