Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE®
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): I.SPACE®
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: 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)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anterior segment of the eye; hyaluronic acid; corneal endothelium; surgery