Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation

Cataracts Clinical Trial

Official title:

Clinical Investigation of Corneal Incision Size After IOL Implantation With Preloaded Delivery Devices and a Manual Delivery Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826421
• Other study ID #: ILN296-P001
• Status: Completed
• Phase: N/A
• Start date: July 4, 2016
• Est. completion date: November 29, 2016

Study information

• Verified date: July 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: November 29, 2016
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Able to comprehend and sign a statement of informed consent;

• Willing and able to complete all required postoperative visits;

• Cataract;

• Planned cataract removal by phacoemulsification;

• Calculated lens power from 18.0 through 27.0 D inclusive;

• Preoperative astigmatism <1.0D;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Systemic disease that affects the cornea;

• Any inflammation or edema of the cornea;

• Previous or planned refractive or corneal surgery during the subject's participation in the study;

• Previous corneal transplant;

• Previous retinal detachment;

• Pregnancy or lactation, current or planned, during the course of the study;

• Current participation in another investigational drug or device study that may confound the results of this investigation;

• Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• UltraSert Preloaded Delivery System
Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject
• iTec Preloaded Delivery System
Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
• iSert Preloaded Delivery System
Includes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject
• Monarch III D Manual IOL Delivery System
Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)	Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.	Day 0, operative day
Secondary	Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)	Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.	Day 0, operative day

External Links

•   Results from the Novartis Clinical Trial Results Website