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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.
In this randomized, clinical trial, three types of injectors were compared :
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autosert Group | Placebo Comparator | Procedure / Surgery : Intraocular lens implantation with Autosert injector |
|
| Royale Group | Placebo Comparator | Procedure / Surgery : Intraocular lens implantation with Royale Injector |
|
| Monarch III Injector | Placebo Comparator | Procedure / Surgery : Intraocular lens implantation with Monarch III group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular lens implantation | Procedure | Intraocular lens implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incision enlargement in mm | 1 minute after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| abhay r vasavada, ms, frcs | iladevi cataract & iol research centre | Principal Investigator |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019654 | Lens Implantation, Intraocular |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
|