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

NCT05146310 | Completed

• 1 other identifier: 2021-A01486-35
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

anterior segment of the eye; hyaluronic acid; corneal endothelium; surgery

Outcome Measures

Primary Outcomes (1)

• Mean percent change of Corneal Endothelium Cells (CEC) density

  Mean percent change of CEC density at 3 months (90 days) post-operation from Baseline. The effectiveness of I.SPACE® will be demonstrated if the CEC density loss is statistically non-superior to a pre-specified threshold of 10% (non-inferiority to -10%).

  3 months (90 days)

Secondary Outcomes (9)

• Intraocular space maintenance evaluation

  Baseline (surgery)

• Surgeon's satisfaction evaluation

  Baseline (surgery)

• Mean percent change of CEC density

  30 days

• Mean change in Intraocular Pressure (IOP)

  6 hours, 24 hours, 7 days, 30 days and 90 days.

• Percentage of eyes with IOP spikes ≥ 30 millimeter of mercury (mmHg)

  6 hours, 24 hours, 7 days, 30 days and 90 days.

Study Arms (1)

Treated eye

EXPERIMENTAL

Eye is treated at Baseline visit (V1)

Device: I.SPACE®

Interventions

I.SPACE® DEVICE

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.

Treated eye

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having at least one eye with cataract (mild or moderate severity) based on subjective ophthalmic examination by the investigator.
• Informed of the clinical investigation and having given freely and expressly his/her informed consent.
• Affiliated to a health social security system.
• Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before screening visit.

You may not qualify if:

• In terms of population
• Pregnant or breastfeeding women or planning a pregnancy during the clinical investigation.
• Deprived of their freedom by administrative or legal decision or under guardianship.
• Known hypersensitivity to one of the investigational medical device (IMD) ingredients.
• One-eyed patients.
• In terms of associated pathology
• Pre-existing :
• Glaucoma,
• severe myopia,
• diabetic retinopathy,
• retinal vascular disease,
• Acute ocular disease or external infection or internal infection or uveitis prior to surgery,
• Known ocular disease/pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention (other than cataract surgery) during the course of the study.
• Any causes of compromised aqueous humor outflow.
• History of :

Sponsors & Collaborators

• Laboratoires Vivacy: lead
• International Clinical Trials Association: collaborator
• Inferential: collaborator

Study Sites (3)

Clinique Ophtalmologique Thiers

Bordeaux, 33100, France

Location

Centre rétine Gallien

Bordeaux, 33200, France

Location

Vision Sud

Marseille, 13008, France

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• SANTIAGO Pierre-Yves, Dr

  Institut Ophtalmologique de l'Ouest Jules Verne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One group of patient treated with I.SPACE® (instilled in the anterior chamber of the eye and adjusted according to the volume of the aqueous humour)

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 6, 2021
• Study Start: December 6, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

FR (3)