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

Cataract Clinical Trial

Official title: Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE® Ophthalmic Viscosurgical Device

Status Completed

Clinical Trial 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.

Clinical Trial Description

PROMIR is a prospective, multicenter, non-comparative post-marketing study of a class IIb medical device (medical device regulatory classification IIb).

This uncontrolled open-label study investigates the efficacy and safety of I.SPACE® in corneal endothelium protection and intraocular space maintain.

The study duration is 3 months with a screening visit (V0) up to 14 days before injection, the baseline visit (injection of I.SPACE®), V1) and 5 follow-up visits after 6 hours, 24 hours, 7 days, 30 days and 90 days (V1' to V5). It is envisaged to enroll 80 patients with planned cataract surgery for at least 1 eye in France to obtain at least 68 evaluable patients, which will be monitored over 3 months after baseline injection of I.SPACE® .

The primary endpoint is defined as the mean percent change of CEC density at 3 months (90 days) post-operation (V5) from Baseline (V0). 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%).

Surgeon's satisfaction after cataract surgery (questionnaire) will be evaluated at V1.

Protection of corneal endothelium (Mean percent change of CEC density) will be also assessed at V4.

Mean change in Intraocular Pressure (IOP), percentage of eyes with IOP spikes ≥ 30mm mmHg, intraocular inflammation and safety will be assessed at all timepoints.

Corneal thickness will be assessed at V2,V3 and V5. Mean Snellen monocular Uncorrected Distance Visual Acuities (UCDVA), Best Corrected Distance Visual Acuities (BCDVA) and ocular symptoms will be assessed at V2, V3, V4 and V5. ;

Related Conditions & MeSH terms

• Cataract

• NCT number: NCT05146310
• Study type: Interventional
• Source: Laboratoires Vivacy
• Status: Completed
• Phase: N/A
• Start date: December 6, 2021
• Completion date: March 1, 2023