Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
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| ClinicalTrials.gov Identifier: NCT03660865 |
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Recruitment Status :
Recruiting
First Posted : September 7, 2018
Last Update Posted : December 24, 2018
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Sponsor:
RxSight, Inc.
Information provided by (Responsible Party):
RxSight, Inc.
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Brief Summary:
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available monofocal IOL will be used to compare the safety and effectiveness of the LAL.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aphakia Cataract | Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) Device: Control monofocal IOL | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other. |
| Masking: | None (Open Label) |
| Masking Description: | Select post operative assessments will be performed on both the experimental and control eye by an examiner who will be masked to the eye assignments. |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery |
| Actual Study Start Date : | August 28, 2018 |
| Estimated Primary Completion Date : | September 1, 2019 |
| Estimated Study Completion Date : | September 1, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD)
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
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Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Primary eye will receive Light adjustable lens with Light delivery Device treatments |
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Active Comparator: Control monofocal IOL
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control monofocal IOL.
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Device: Control monofocal IOL
Fellow eye will receive control monofocal IOL |
Primary Outcome Measures :
- Magnitude of manifest cylinder (MRCYL) compared between the two study groups, LAL and Control [ Time Frame: Postop Month 6 ]
- Absolute Manifest Refraction Spherical Equivalent (MRSE) compared between the two study groups, LAL and Control [ Time Frame: Postop Month 6 ]
- One sided upper 95% confidence limit of the percentage of LAL implanted eyes with BCDVA of 20/40 or better is higher than the performance rate of 92.5% [ Time Frame: Postop Month 6 ]
Secondary Outcome Measures :
- Uncorrected distance visual acuity (UCDVA) [ Time Frame: Postop Month 6 ]
- Uncorrected distance visual acuity (UCDVA) for subjects measured with keratometric cylinder (Kcyl) <0.75 D in both eyes at the preoperative examination [ Time Frame: Postop Month 6 ]
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of an intraocular lens (IOL).
- Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
- History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes.
- Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/40 or worse with or without a glare source in both eyes.
- Willing and able to comply with the requirements for study specific procedures and visits.
- Able to complete a written questionnaire in English.
Exclusion Criteria:
- Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye.
- Pre-existing macular disease in either eye.
- Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
- History of uveitis in either eye.
- Evidence of ectasia in either eye.
- Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
- Subjects taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation.
- Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
- History of ocular herpes simplex virus in either eye.
Information from the National Library of Medicine
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): NCT03660865
Contacts
| Contact: David Goffredo | 949-421-5463 ext 300 | dgoffredo@rxsight.com | |
| Contact: Maureen O'Connell | 978-207-1245 | moconnell@rxsight.com |
Locations
| United States, Kansas | |
| Discover Vision Centers | Recruiting |
| Leawood, Kansas, United States, 66211 | |
| Contact: Clinical Research Coordinator for Dr. John Doane 816-350-6903 | |
| Principal Investigator: John F Doane, MD | |
| United States, Ohio | |
| Cleveland Eye Clinic | Recruiting |
| Brecksville, Ohio, United States, 44141 | |
| Contact: Erin Kus-Kreidler 216-503-6535 ekus-kreidler@clevelandeyeclinic.com | |
| Principal Investigator: William F Wiley, MD | |
| United States, South Dakota | |
| Vance Thompson Vision Clinic | Recruiting |
| Sioux Falls, South Dakota, United States, 57108 | |
| Contact: Keeley Puls, Director of Research, CCRC 605-361-3937 | |
| Principal Investigator: Vance Thompson, MD, FACS | |
| United States, Texas | |
| Slade & Baker Vision | Recruiting |
| Houston, Texas, United States, 77027 | |
| Contact: Research Department 713-626-5544 | |
| Principal Investigator: Steven Slade, MD, FACS | |
| Focal Point Vision | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Lisa Navarro 210-614-3600 ext 118 navarro@focalpointvision.com | |
| Principal Investigator: James D Lehmann, MD | |
| United States, Utah | |
| The Eye Institute of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84107 | |
| Contact: Laurie Adams 801-266-2283 | |
| Principal Investigator: Robert J Cionni, MD | |
Sponsors and Collaborators
RxSight, Inc.
| Responsible Party: | RxSight, Inc. |
| ClinicalTrials.gov Identifier: | NCT03660865 History of Changes |
| Other Study ID Numbers: |
CSP-027 |
| First Posted: | September 7, 2018 Key Record Dates |
| Last Update Posted: | December 24, 2018 |
| Last Verified: | December 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | Yes | |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes | |
| Pediatric Postmarket Surveillance of a Device Product: | No | |
Keywords provided by RxSight, Inc.:
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Light Adjustable Lens Intraocular lens LAL |
Additional relevant MeSH terms:
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Cataract Aphakia Lens Diseases Eye Diseases |