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Comparison of the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD

NCT05832749 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 296

Last updated 2023-04-27

No results posted yet for this study

Summary

Prospective, randomized, subject/evaluator-masked post market clinical study at up to 2 sites at Gemini eye clinic in Czech Republic. Randomization will be done by the eye surgeon. The purpose of this post market clinical trial is to compare the safety and efficacy of Ophtesis Bio 3% with a similar 3% sodium hyaluronate OVD in routine cataract surgery.

Conditions

  • Bilateral Cataract
  • Unilateral Cataract

Interventions

DEVICE

Ophtesis Bio 3% ophthalmic viscosurgical device

Intraocular surgery of the anterior segment, including cataract extraction and intraocular lens (IOL) implantation. The viscoelastic properties of OphtesisBio 3.0% allow lubrication, support and protection of ocular tissues during ophthalmic surgery. Maintains the depth of the anterior chamber during surgery, allows for efficient manipulation with reduced trauma to the corneal endothelium and other surrounding tissues.

DEVICE

Healon Endocoat 3% ophthalmic viscosurgical device

Healon@ EndoCoat OVD is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including: * Cataract surgery with an intraocular lens * Cataract surgery without an intraocular lens * Secondary intraocular lens implantation Healon@ EndoCoat maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.

Sponsors & Collaborators

  • Gemini Eye Clinic

    lead INDUSTRY

Principal Investigators

  • Pavel Stodulka, MD · Gemini Eye Clinic

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2023-04-30
Completion
2023-05-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832749 on ClinicalTrials.gov