Intra and Postoperative Outcomes With 3 Injectors

Study Overview
=================
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 : 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

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

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: Intraocular lens implantation
* Device: Autosert Injector
* Device: Royale Injector
* Device: Monarch III Injector


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Autosert Group<br>Procedure / Surgery : Intraocular lens implantation with Autosert injector | Procedure: Intraocular lens implantation<br>* Intraocular lens implantation<br>Device: Autosert Injector<br>* Motorised injection device for intraocular lens implantation<br>|
| Placebo Comparator: Royale Group<br>Procedure / Surgery : Intraocular lens implantation with Royale Injector | Procedure: Intraocular lens implantation<br>* Intraocular lens implantation<br>Device: Royale Injector<br>* Manual, plunger type injection device for intraocular lens implantation<br>|
| Placebo Comparator: Monarch III Injector<br>Procedure / Surgery : Intraocular lens implantation with Monarch III group | Device: Monarch III Injector<br>* Manual, screw type injection device for intraocular lens implantation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision enlargement in mm |  | 1 minute after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraocular lens implantation