LensOne Heads Toward Pivotal Trial - Report - MDSpire

LensOne Heads Toward Pivotal Trial

  • By

  • Frank Brodie, MD, MBA

  • Diana V. Do, MD

  • June 1, 2026

  • 2 min

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Clinical Report: LensOne Heads Toward Pivotal Trial

Overview

The LensOne prosthetic capsular bag is under evaluation in the upcoming GOLDEN GATE trial, which aims to assess its performance in a multicenter prospective setting.

Background

The management of aphakia or dislocated intraocular lenses (IOLs) is a significant challenge in ophthalmology, particularly in eyes lacking capsular support. Traditional approaches include various fixation techniques.

Data Highlights

No numerical data provided in the source material.

Key Findings

  • The LensOne prosthetic capsular bag shows a safety and efficacy profile.
  • It demonstrates minimal tilt and decentration of lenses.
  • Performance of the LensOne device is comparable to in-the-bag phaco techniques.
  • The GOLDEN GATE trial is set to begin this fall as a multicenter prospective pivotal trial.
  • Long-term safety follow-up data has been established for the prosthetic capsular bag.

Clinical Implications

The initiation of the GOLDEN GATE trial will be critical in validating these early results in a larger population.

Conclusion

Further evaluation of the LensOne prosthetic capsular bag is pending from the upcoming pivotal trial.

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  8. https://www.escrs.org/media/ooama3sf/full-extended-guideline-24092025.pdf
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