CataractPROMIRNCT05146310
Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE®
A study testing I.SPACE® in people with Cataract, run by Laboratoires Vivacy at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Cataract
- What is being tested?
- I.SPACE®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Dec 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique Ophtalmologique Thiers
Bordeaux, 33100
Centre rétine Gallien
Bordeaux, 33200
Vision Sud
Marseille, 13008
About this study
Official title: Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE® Ophthalmic Viscosurgical Device
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- I.SPACE®
- Keywords
- anterior segment of the eye, hyaluronic acid, corneal endothelium, surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treated eye | Experimental | Eye is treated at Baseline visit (V1) Receives: Device: I.SPACE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 3 months (90 days)
Secondary outcomes (9)
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".
Measured: Baseline (surgery)
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".
Measured: Baseline (surgery)
Mean percent change of CEC density
Mean percent change of CEC density evaluated from baseline to 30 days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours, 7 days, 30 days and 90 days.
Report of adverse effects
Evaluation of product safety by adverse event collection throughout the study
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start6 Dec 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association, Inferential
- Responsible party
- Sponsor
- Investigators
- SANTIAGO Pierre-Yves, Dr, Principal investigator, Institut Ophtalmologique de l'Ouest Jules Verne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146310
- Sponsor's protocol ID
- 2021-A01486-35
- Acronym
- PROMIR
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE® Ophthalmic Viscosurgical Device
- ClinicalTrials.gov ID
- NCT05146310
- Acronym / sponsor ID
- PROMIR / 2021-A01486-35
- Conditions
- Cataract
- Keywords
- anterior segment of the eye, hyaluronic acid, corneal endothelium, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association, Inferential
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| Treated eye | Experimental | Device: I.SPACE®Eye is treated at Baseline visit (V1) |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treated eye |
Primary outcome
Mean percent change of Corneal Endothelium Cells (CEC) density
Time frame: 3 months (90 days)
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%).
9 secondary outcomes
Intraocular space maintenance evaluation
Time frame: Baseline (surgery)
Surgeon's satisfaction evaluation
Time frame: Baseline (surgery)
Mean percent change of CEC density
Time frame: 30 days
Mean change in Intraocular Pressure (IOP)
Time frame: 6 hours, 24 hours, 7 days, 30 days and 90 days.
Percentage of eyes with IOP spikes ≥ 30 millimeter of mercury (mmHg)
Time frame: 6 hours, 24 hours, 7 days, 30 days and 90 days.
Corneal thickness evaluation
Time frame: 24 hours, 7 days and 90 days.
Intraocular inflammation evaluation
Time frame: 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
Time frame: 24 hours, 7 days, 30 days and 90 days.
Report of adverse effects
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SANTIAGO Pierre-Yves, Dr principal investigator
Institut Ophtalmologique de l'Ouest Jules Verne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I.SPACE® in people with Cataract, run by Laboratoires Vivacy at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent change of Corneal Endothelium Cells (CEC) density (time frame: 3 months (90 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.