Intra and Postoperative Outcomes With 3 Injectors

Iladevi Cataract and IOL Research Center

Status: Completed

Conditions: Cataract

Treatments: Device: Monarch III Injector; Device: Royale Injector; Device: Autosert Injector; Procedure: Intraocular lens implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02466256

2014-005

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

Autosert Group

Placebo Comparator group

Description:

Procedure / Surgery : Intraocular lens implantation with Autosert injector

Treatment:

Device: Autosert Injector

Procedure: Intraocular lens implantation

Royale Group

Placebo Comparator group

Description:

Procedure / Surgery : Intraocular lens implantation with Royale Injector

Treatment:

Device: Royale Injector

Procedure: Intraocular lens implantation

Monarch III Injector

Placebo Comparator group

Description:

Procedure / Surgery : Intraocular lens implantation with Monarch III group

Treatment:

Device: Monarch III Injector