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OpenTrials
Completed

NCT Number: NCT04529616

Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes

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.

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Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

CODET Vision Institute

Tijuana, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.
  • Age 30 or older 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 zonular laxity or dehiscence.
  • Study eye with diabetes with any evidence of retinopathy.
  • Study eye with history of uveitis.
  • 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.
  • Study eye with history of ocular herpes simplex virus.

Treatment and study plan

Light Adjustable lens (LAL) and Light Delivery Device (LDD)

Device

Eligible eyes will receive Light adjustable lens with Light delivery Device treatments

Primary outcomes

  1. Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better

    Time frame: 3 months post op

    Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing.

  2. Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better

    Time frame: 12 months post op

    Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment

Sponsors and collaborators

Lead sponsor

RxSight, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2020
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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