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

Sponsor
Gemini Eye Clinic (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05832749
Collaborator
(none)
296
3
8.2
98.7
12

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ophtesis Bio 3% ophthalmic viscosurgical device
  • Device: Healon Endocoat 3% ophthalmic viscosurgical device

Detailed Description

The purpose of this clinical study is to evaluate the performance of the Ophtesis Bio 3%. The primary endpoint is the rate of intraocular pressure (IOP) spikes of 30 mmHG or greater at the 7-day postoperative visit. The secondary endpoint will be the rate of user acceptance evaluated using the surgeon questionnaire at the surgery day visit. Other key endpoints will include IOP and IOP change from baseline at the 7-day postoperative visit, rate of inflammation measured using Slip Lamp at the 7-day postoperative visit, and rates of serious and/or device-related adverse events. Number of Subjects/eyes: Up to 296 eyes will be enrolled to achieve approximately 148 operated eyes per group.

Study Design

Study Type:
Observational
Anticipated Enrollment :
296 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-market, Prospective, Randomised, Controlled, Masked Clinical Investigation to Compare the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD (Ophthalmic Viscosurgical Device)
Actual Study Start Date :
Aug 23, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Study Product: Ophtesis Bio 3%

Subjects to receive Ophtesis Bio 3% in one eye

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.

Control Product: Healon Endocoat 3%

Subjects to receive Healon Endocoat 3% in one eye

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.

Outcome Measures

Primary Outcome Measures

  1. Intraocular pressure (IOP) [7 days]

    Rate of intraocular pressure (IOP) spikes of 30 mmHG or greater

  2. Surgeon questionnaire [first day]

    The rate of user acceptance ten questions that can be answered on a scale from 1 to 5, 1 means the worst, 5 the best

Secondary Outcome Measures

  1. Biomicroscopic Slit-Lamp Exam [Pre-operative visit, 7 days]

    Rate of inflammation

  2. IOP change [7 days]

    IOP change from Pre-operative visit at the 7-day postoperative visit

  3. IOP change [first day]

    IOP change from Pre-operative to up to 1 hour post op

  4. Dilated fundus exam [Pre-operative visit, after only if medically indicated]

    Examination to help assess ocular health

  5. Serious and /or Device-Related Adverse Events [first day, 7 days]

    Rates of serious and/or device-related adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Cataract for which extraction and posterior intraocular lens (IOL) implantation have been planned for one or both eyes

  • Clear intraocular media, other than cataract

  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures

  • Signed informed consent

Exclusion Criteria:
  • Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)

  • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject

  • Use of systemic or ocular medications that may affect IOP

  • Known steroid responder

  • Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve

  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes

  • Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gemini Eye Clinic Průhonice Czechia 252 43
2 Gemini Eye Clinic Vyškov Czechia 682 01
3 Gemini Eye Clinic Zlín Czechia 76001

Sponsors and Collaborators

  • Gemini Eye Clinic

Investigators

  • Principal Investigator: Pavel Stodulka, MD, Gemini Eye Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Pavel Stodulka, Chief eye surgeon, Gemini Eye Clinic
ClinicalTrials.gov Identifier:
NCT05832749
Other Study ID Numbers:
  • OVD PMCF study
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Pavel Stodulka, Chief eye surgeon, Gemini Eye Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023