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The objective of this study is to evaluate the ease of use of a modified, disposable contact lens and suction ring assembly.
This will be a prospective, single center clinical trial of up to 300 consecutive eyes of subjects scheduled to undergo ocular surgery requiring an initial incision, specifically, cataract surgery. Subjects will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition.
Subjects will undergo unilateral cataract surgery using the LenSx Laser for one or a combination of the following laser procedures: anterior capsulotomy, laser lens phacofragmentation and corneal incision with implantation of an intraocular lens (IOL). Surgeon and staff comments will be solicited for ergonomic and packaging features of the new disposable contact lens. Subjects will be evaluated intraoperatively to assess comfort of the new disposable contact lens, as well as the completion of anterior capsulotomy, laser lens phacofragmentation and completion of corneal incisions. All patients will be evaluated postoperatively at one day, one week and 1 month to follow the condition of the surgical eye. Further follow up can be performed at the discretion of the surgeon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Other | This is a single arm study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LenSx Laser modified disposable contact lens | Device | Modified Disposable Contact Lens Patient Interface: Like the current disposable contact lens, a single unit is used for each procedure only once, and is then discarded. It is similarly mounted onto the distal end of the system's focusing objective and serves as a sterile barrier between the patient and the laser. In place of a separate suction ring that is used in the current contact lens, the modified contact lens has an integrated suction ring and curved applanation surface. These features result in significantly lower elevation of intraocular pressure and significantly easier application by the surgeon in preliminary testing. Identical to the current contact lens, the suction ring is applied around the patient's limbus and mild suction is applied to stabilize the eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Disposable contact lens successfully applied to the eye | Was the Contact Lens successfully applied to the eye? Yes or No. | Intraoperative (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical evaluation of Corneal Incision | Was the corneal incision complete? | Intraoperative (Day 0) |
| Standard Outcomes Measurements | Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Slade, MD | Slade and Baker Vision Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slade and Baker Vision Center | Houston | Texas | 77027 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Pre-operative (Day -60 to Day -1) |
| Surgical evaluation of capsulotomy | Was capsulotomy complete? Yes or No. | Intraoperative (Day 0) |
| Surgical evaluation of fragmentation | Was lens fragmentation complete? Yes or No. | Intraoperative (Day 0) |
| Standard outcomes measurement | Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events | 1 week (5 to 10 days post operative) |
| Standard outcomes measurement | Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events | 1 day (24 to 48 hours postoperative) |
| Standard outcomes measurement | Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events | 1 month (21 to 42 days postoperative) |