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Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE®

NCT05146310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-11-29

No results posted yet for this study

Summary

I.SPACE® is a hyaluronic acid injectable gel CE (European Conformity) marketed since 2010. It is indicated for use as a surgical aid in ophthalmic anterior segment surgery. The aim is to protect the corneal endothelium and maintains the intraocular space.The product should be instilled in the anterior chamber of the eye and adjusted according to the volume of the aqueous humour.

In this study, 80 patients aged from 18 to 84 years' old at inclusion, who have at least one eye with cataract (mild to moderate severity) based on subjective ophthalmic examination by the investigator, who have given his/her informed consent and meet all the eligibility criteria, will be enrolled.

Subjects will come to a total of 7 visits over a period of 3 months. Protection of corneal endothelium (Mean percent change of CEC density) after baseline injection will be assessed. Surgeon's satisfaction during cataract surgery, mean change in Intraocular Pressure (IOP), percentage of eyes with IOP spikes ≥ 30mm mmHg, corneal thickness, intraocular inflammation, Mean Snellen monocular Uncorrected Distance Visual Acuities (UCDVA), Best Corrected Distance Visual Acuities (BCDVA) and safety will be also assessed.

Conditions

  • Cataract

Interventions

DEVICE

I.SPACE®

I.SPACE® is a viscoelastic sodium hyaluronate gel use as a surgical aid in ophthalmic anterior segment surgery by maintaining the intraocular space and protecting the corneal endothelium. The baseline injection is performed at V1. The volume of product to use will be at the Investigator discretion, and will be completely removed after surgery.

Sponsors & Collaborators

  • International Clinical Trials Association

    collaborator OTHER

  • Inferential

    collaborator INDUSTRY

  • Laboratoires Vivacy

    lead INDUSTRY

Principal Investigators

  • SANTIAGO Pierre-Yves, Dr · Institut Ophtalmologique de l'Ouest Jules Verne

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • France

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 NCT05146310 on ClinicalTrials.gov