New Disposable Contact Lens Patient Interface For The Lensx Laser
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|ClinicalTrials.gov Identifier: NCT01141985|
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : October 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cataract Corneal Disease||Device: LenSx Laser modified disposable contact lens||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation Of A New Disposable Contact Lens Patient Interface For The Lensx Laser In Cataract And Corneal Surgery|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
This is a single arm study.
Device: LenSx Laser modified disposable contact lens
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.
- Disposable contact lens successfully applied to the eye [ Time Frame: Intraoperative (Day 0) ]Was the Contact Lens successfully applied to the eye? Yes or No.
- Surgical evaluation of Corneal Incision [ Time Frame: Intraoperative (Day 0) ]Was the corneal incision complete?
- Standard Outcomes Measurements [ Time Frame: Pre-operative (Day -60 to Day -1) ]Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
- Surgical evaluation of capsulotomy [ Time Frame: Intraoperative (Day 0) ]Was capsulotomy complete? Yes or No.
- Surgical evaluation of fragmentation [ Time Frame: Intraoperative (Day 0) ]Was lens fragmentation complete? Yes or No.
- Standard outcomes measurement [ Time Frame: 1 week (5 to 10 days post operative) ]Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
- Standard outcomes measurement [ Time Frame: 1 day (24 to 48 hours postoperative) ]Standard measurements of Visual Acuity, Manifest Refraction, Slit Lamp Examination, Fundus Examination, Intraocular pressure, Complications and Adverse Events
- Standard outcomes measurement [ Time Frame: 1 month (21 to 42 days postoperative) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141985
|United States, Texas|
|Slade and Baker Vision Center|
|Houston, Texas, United States, 77027|
|Principal Investigator:||Stephen Slade, MD||Slade and Baker Vision Center|