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OpenTrials
Completed

NCT Number: NCT02466256

Intra and Postoperative Outcomes With 3 Injectors

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In this randomized, clinical trial, three types of injectors were compared :

  • Manual, screw type injector (Monarch III)
  • Manual, plunger type injector (Royale, ASICO)
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraocular lens implantation

Procedure

Intraocular lens implantation

Autosert Injector

Device

Motorised injection device for intraocular lens implantation

Royale Injector

Device

Manual, plunger type injection device for intraocular lens implantation

Monarch III Injector

Device

Manual, screw type injection device for intraocular lens implantation

Primary outcomes

  1. Incision enlargement in mm

    Time frame: 1 minute after surgery

Secondary outcomes

  1. Trypan Blue ingress into the anterior chamber in log units

    Time frame: 1 minute after surgery

  2. Incision morphology - qualitative

    Time frame: 1 day, 1 week and 1 month after surgery

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 9, 2015
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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