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Effectiveness & Safety of I.SPACE® Ophthalmic Viscosurgical Device in Protecting Corneal Endothelium (PROMIR)

Primary Purpose

Cataract

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

I.SPACE®

About this trial

This is an interventional treatment trial for Cataract focused on measuring anterior segment of the eye, hyaluronic acid, corneal endothelium, surgery

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient aged from 18 to 84 years' old at inclusion.
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.

Exclusion Criteria:

In terms of population

Pregnant or breastfeeding women or planning a pregnancy during the clinical investigation.
Participating at the same time in another clinical investigation or is in an exclusion period of one.
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 :
- Intraocular surgery,
- ocular trauma,
- lens pseudoexfoliation capsular syndrome,
- ocular hypertension > 21 mmHg without treatment
- chronic or recurrent inflammatory eye disease or a congenital ocular anomaly such as Marfan's Syndrome
Endothelial cell density at baseline less than 2000 cells/mm2 or poor quality photograph of preoperative endothelial cells (all reasons including corneal abnormalities).
Any abnormalities that prevented reliable Goldmann applanation tonometry.
Eyes with Axial Length (AL) >25 mm or < 20 mm or eyes with small pupil diameter, pathologic miosis or pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils);

Relating to previous and ongoing treatments:

Patient currently treated with Tamsulosine and other alpha 1 antagonist or psychotics

Sites / Locations

Clinique d'ANJOU Pôle de consultation TassignyRecruiting
Clinique Ophtalmologique ThiersRecruiting
Centre rétine GallienRecruiting
Vision SudRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated eye

Arm Description

Eye is treated at Baseline visit (V1)

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

Intraocular space maintenance evaluation

Evaluation of the intraocular space maintenance (questionnaire) using a 4-point scale, assessed by the surgeon, at Baseline. The 4-point scale contains the following categories : "Not at all", "Slightly"; "Very much" and "Extremely".

Surgeon's satisfaction evaluation

Evaluation of surgeon's satisfaction after cataract surgery (questionnaire) using a 4-point scale assessed by the surgeon, at Baseline. Each cataract surgery stage should be evaluated with a 4-point scale containing the following categories : "Full chamber maintained ", "Work space maintained"; "Shallow" and "flat".

Mean percent change of CEC density

Mean percent change of CEC density evaluated from baseline to 30 days.

Mean change in Intraocular Pressure (IOP)

Mean change in IOP, measured by Goldmann applanation tonometry, from baseline to 6 hours, 24 hours, 7 days, 30 days and 90 days.

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

Percentage of eyes with IOP spikes ≥ 30mmHg, measured by Goldmann applanation tonometry, at 6 hours, 24 hours, 7 days, 30 days, and 90 days.

Corneal thickness evaluation

Corneal thickness, evaluated at 24 hours, 7 days and 90 days.

Intraocular inflammation evaluation

Intraocular inflammation, evaluated by slit-lamp examination at 6 hours, 24 hours, 7 days, 30 days and 90 days.

Mean Snellen monocular Uncorrected Distance Visual Acuities (UCDVA), Best Corrected Distance Visual Acuities (BCDVA) and ocular symptoms

UCDVA and BCDVA under photopic lighting conditions and ocular symptoms, at 24 hours, 7 days, 30 days and 90 days. Ocular symptoms will be subjectively assessed by interrogating the patient. If a subject reports a symptoms, the level of severity should be reported.

Report of adverse effects

Evaluation of product safety by adverse event collection throughout the study

Full Information

NCT ID

NCT05146310

First Posted

November 22, 2021

Last Updated

May 17, 2022

Sponsor

Laboratoires Vivacy

Collaborators

International Clinical Trials Association, Inferential

1. Study Identification

Unique Protocol Identification Number

NCT05146310

Brief Title

Effectiveness & Safety of I.SPACE® Ophthalmic Viscosurgical Device in Protecting Corneal Endothelium

Acronym

PROMIR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 6, 2021 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoires Vivacy

Collaborators

International Clinical Trials Association, Inferential

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treated eye

Arm Type

Experimental

Arm Description

Eye is treated at Baseline visit (V1)

Intervention Type

Device

Intervention Name(s)

I.SPACE®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean percent change of Corneal Endothelium Cells (CEC) density

Description

Time Frame

3 months (90 days)

Secondary Outcome Measure Information:

Title

Intraocular space maintenance evaluation

Description

Time Frame

Baseline (surgery)

Title

Surgeon's satisfaction evaluation

Description

Time Frame

Baseline (surgery)

Title

Mean percent change of CEC density

Description

Mean percent change of CEC density evaluated from baseline to 30 days.

Time Frame

30 days

Title

Mean change in Intraocular Pressure (IOP)

Description

Mean change in IOP, measured by Goldmann applanation tonometry, from baseline to 6 hours, 24 hours, 7 days, 30 days and 90 days.

Time Frame

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

Title

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

Description

Percentage of eyes with IOP spikes ≥ 30mmHg, measured by Goldmann applanation tonometry, at 6 hours, 24 hours, 7 days, 30 days, and 90 days.

Time Frame

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

Title

Corneal thickness evaluation

Description

Corneal thickness, evaluated at 24 hours, 7 days and 90 days.

Time Frame

24 hours, 7 days and 90 days.

Title

Intraocular inflammation evaluation

Description

Intraocular inflammation, evaluated by slit-lamp examination at 6 hours, 24 hours, 7 days, 30 days and 90 days.

Time Frame

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

Title

Mean Snellen monocular Uncorrected Distance Visual Acuities (UCDVA), Best Corrected Distance Visual Acuities (BCDVA) and ocular symptoms

Description

Time Frame

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

Title

Report of adverse effects

Description

Evaluation of product safety by adverse event collection throughout the study

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient aged from 18 to 84 years' old at inclusion. 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. Exclusion Criteria: In terms of population Pregnant or breastfeeding women or planning a pregnancy during the clinical investigation. Participating at the same time in another clinical investigation or is in an exclusion period of one. 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 : Intraocular surgery, ocular trauma, lens pseudoexfoliation capsular syndrome, ocular hypertension > 21 mmHg without treatment chronic or recurrent inflammatory eye disease or a congenital ocular anomaly such as Marfan's Syndrome Endothelial cell density at baseline less than 2000 cells/mm2 or poor quality photograph of preoperative endothelial cells (all reasons including corneal abnormalities). Any abnormalities that prevented reliable Goldmann applanation tonometry. Eyes with Axial Length (AL) >25 mm or < 20 mm or eyes with small pupil diameter, pathologic miosis or pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils); Relating to previous and ongoing treatments: Patient currently treated with Tamsulosine and other alpha 1 antagonist or psychotics

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicolas WEIL

Phone

+33 617 918 361

Nicolas.wiel@icta.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

SANTIAGO Pierre-Yves

Organizational Affiliation

Institut Ophtalmologique de l'Ouest Jules Verne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique d'ANJOU Pôle de consultation Tassigny

City

Angers

ZIP/Postal Code

49000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bertrand BOUSSION

Facility Name

Clinique Ophtalmologique Thiers

City

Bordeaux

ZIP/Postal Code

33100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Quentin DE BOSREDON

Facility Name

Centre rétine Gallien

City

Bordeaux

ZIP/Postal Code

33200

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurent VELASQUE

Facility Name

Vision Sud

City

Marseille

ZIP/Postal Code

13008

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louis HOFFART

12. IPD Sharing Statement

Learn more about this trial

Effectiveness & Safety of I.SPACE® Ophthalmic Viscosurgical Device in Protecting Corneal Endothelium

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