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The study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity in the post-operative period.
The study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity in the post-operative period. By comparing these two different IOP settings, we can determine the impact of IOP on surgical efficiency and the quality of post-operative results, especially in relation to corneal health.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjusting intraocular pressure (IOP) settings | Device | Investigating whether adjusting IOP settings near physiologic levels during cataract surgery could potentially lead to better surgical outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Central Corneal Thickness | Measurement by Pentacam | 1 day following surgery for each eye |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Inflammation | Summed up inflammation score | 1 day following surgery for each eye |
| Total BSS fluid usage during phaco emulsification | Balance salt solution fluid usage |
| Measure | Description | Time Frame |
|---|---|---|
| BSS usage (Total) | Total BSS usage | Day of surgery for each eye |
| Ultrasound time | Cumulative Dissipated Energy (CDE) | Day of surgery for each eye |
Inclusion Criteria:
Exclusion Criteria:
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This will be a multisite, prospective, randomized, contralateral-eye controlled, open-label clinical study, in which a maximum of 160 eyes will be treated with the Alcon Centurion System with Active Sentry during cataract surgery.
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| Name | Affiliation | Role |
|---|---|---|
| John Hovanesian, MD | Harvard Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Laguna Hills | California | 92563 | United States |
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| Day of surgery for each eye |
| Aspiration time | Aspiration Time | Day of surgery for each eye |
| Use of opioids during cataract surgery | Opioid use | Day of surgery for each eye |
| Incidence of reverse pupillary block during cataract surgery | Did this occur during surgery - yes or no | Day of surgery for each eye |
| Uncorrected best corrected, and best corrected 25% low contrast visual acuity | Best corrected vision | At the 1 day postoperative, 7 days post operative, and 28 days post operative for each eye |
| Grade of slit lamp corneal edema | Corneal edema grade | 1 day following surgery for each eye |
| Corneal densitometry | Corneal density | At baseline, 1 day post-operative, and 7 day post-operative for each eye |
| Change in the presence of posterior vitreous detachment/incidence | Was there a change - yes or no | At baseline and 28 days post-operative of each eye |