Intra and Postoperative Outcomes With 3 Injectors

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466256
• Other study ID #: 2014-005
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: June 8, 2015
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Intraocular lens implantation
Intraocular lens implantation

Device:
• Autosert Injector
Motorised injection device for intraocular lens implantation
• Royale Injector
Manual, plunger type injection device for intraocular lens implantation
• Monarch III Injector
Manual, screw type injection device for intraocular lens implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incision enlargement in mm		1 minute after surgery	No
Secondary	Trypan Blue ingress into the anterior chamber in log units		1 minute after surgery	No
Secondary	Incision morphology - qualitative		1 day, 1 week and 1 month after surgery	No