N/A
N=109
Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation
Cataracts
Bottom Line
View on ClinicalTrials.gov: NCT02826421 ↗Enrolled (actual)
109
Serious AEs
0.9%
Results posted
Jul 2017
Primary outcome: Primary: Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert) — 2.35; 2.47; 2.54 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UltraSert Preloaded Delivery System (Device); iTec Preloaded Delivery System (Device); iSert Preloaded Delivery System (Device); Monarch III D Manual IOL Delivery System (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert) |
2.35; 2.47; 2.54 | — |
| SECONDARY Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D) |
2.35; 2.49 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02826421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.