Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD)
|
Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
|
Outcome Measures
Primary Outcome Measures
- Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better [3 months post op]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.
-
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
-
Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
-
Willing and able to comply with the requirements for study specific procedures and visits.
Exclusion Criteria:
-
Study eye with pseudoexfoliation.
-
Study eye with diabetes with any evidence of retinopathy.
-
Study eye with evidence of glaucomatous optic neuropathy.
-
Study eye with history of uveitis.
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Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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.
-
Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
-
Study eye with history of ocular herpes simplex virus.
-
Study eye with history of a congenital color vision defect
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CODET Vision Institute | Tijuana | Mexico |
Sponsors and Collaborators
- RxSight, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- CSP-032
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
---|---|
Arm/Group Description | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments |
Period Title: Overall Study | |
STARTED | 66 |
COMPLETED | 64 |
NOT COMPLETED | 2 |
Baseline Characteristics
Arm/Group Title | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
---|---|
Arm/Group Description | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments |
Overall Participants | 66 |
Overall Eyes | 111 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
67.4
(7.2)
|
Sex: Female, Male (Count of Participants) | |
Female |
42
63.6%
|
Male |
24
36.4%
|
Race/Ethnicity, Customized (Count of Participants) | |
Hispanic |
66
100%
|
White |
0
0%
|
Black |
0
0%
|
Other |
0
0%
|
Region of Enrollment (participants) [Number] | |
Mexico |
66
100%
|
Eyes (Eyes) [Count of Units] | |
OD |
56
|
OS |
55
|
Outcome Measures
Title | Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better |
---|---|
Description | |
Time Frame | 3 months post op |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
---|---|
Arm/Group Description | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments |
Measure Participants | 66 |
Measure Eyes | 109 |
Count of Units [Eyes] |
101
|
Adverse Events
Time Frame | Through study completion, an average of 3 months | |
---|---|---|
Adverse Event Reporting Description | The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected. | |
Arm/Group Title | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | |
Arm/Group Description | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments | |
All Cause Mortality |
||
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | ||
Affected / at Risk (%) | # Events | |
Total | 0/66 (0%) | |
Serious Adverse Events |
||
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | ||
Affected / at Risk (%) | # Events | |
Total | 0/111 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | ||
Affected / at Risk (%) | # Events | |
Total | 25/111 (22.5%) | |
Eye disorders | ||
Anterior Capsule Rupture | 1/111 (0.9%) | 1 |
BCDVA Drop of 10 letters of more | 1/111 (0.9%) | 2 |
Corneal Erosion | 1/111 (0.9%) | 1 |
Corneal Guttata | 2/111 (1.8%) | 2 |
Cystoid Macular Edema | 1/111 (0.9%) | 1 |
Iris Atrophy | 1/111 (0.9%) | 1 |
Iritis | 3/111 (2.7%) | 4 |
Posterior Capsular Opacity | 2/111 (1.8%) | 2 |
Superficial Punctate Keratitis | 11/111 (9.9%) | 11 |
Vision changes including night vision changes | 2/111 (1.8%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Jeffrey Ha, Senior Director of Clinical Research |
---|---|
Organization | RxSight |
Phone | 949-521-7870 |
jha@rxsight.com |
- CSP-032