Diabetic RetinopathyNNIOP-PHACONCT06617273
Cataract Surgery with Near Normal Eye Pressure in Patients with Diabetic Retinopathy
A study testing Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulation in people with Diabetic Retinopathy and Cataract, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Diabetes mellitus is a chronic metabolic disease that can lead to visual impairment and eye complications such as diabetic retinopathy and diabetic macular edema. Diabetics are considered a vulnerable patient group for cataract surgery, as microincision phacoemulsification (MICS) in diabetics is associated with a… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Diabetic Retinopathy, Cataract
- What is being tested?
- Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteAustria
- Study dates
- 21 Aug 2024to 30 Sep 2025
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for immediate sequential bilateral microincision cataract surgery
- Diagnosis of Diabetes Mellitus treated with oral medication or insulin therapy and confirmed by HbA1c ≥6,5 %
- Presence of diabetic retinopathy grade ≥1 on the international clinical diabetic retinopathy (ICDR) severity scale
- LOCS 2-4 with no more than 1 grade difference between both eyes
- Male or female patient aged 50 - 85 years of age at time of consent
- Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature
Who cannot join
- Participation in another clinical trial within 30 days before pre-screening and throughout the trial
- Prior intraocular surgery of any type
- History of diabetic macular edema
- Presence of macular edema, defined as central retinal thickness of \>300 µm plus intraretinal or subretinal fluid on OCT within range of 1mm of foveal center
- Presence of any retinal or choroidal disease, other than diabetes, that could affect retinal thickness
- Known history of uveitis
Show all 12Show fewer
- Documented use of systemic or topical steroid or other immunosuppressive medication within the last 3 months
- ACF \>10 ph/ms. ACF difference between right and left eye \> 4ph/ms
- Difference of DRP grading between right and left eye of more than 1 grade (ICDR)
- Inability to measure total macular volume due to, but not limed to, too dense cataract, vitreous bleeding
- Woman of childbearing potential (WOCBP) who is breastfeeding, has a positive urine pregnancy test, is not willing to undergo a urine pregnancy test upon entering or exiting the study, intends to become pregnant during the study, or does not agree to use adequate birth control methods for the duration of the study
- Patients in possession of an active implantable medical device (AIMD)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Innsbruck, University Hospital for Ophthalmology and Optometry
Innsbruck, 6020
About this study
Official title: Near Normal Intraocular Pressure Cataract Surgery in Patients with Diabetic Retinopathy Using Active Anterior Chamber Pressure Sensing and Regulation - a Randomized Controlled Comparative Clinical Trial
Diabetes mellitus is a chronic metabolic disease that can lead to visual impairment and eye complications such as diabetic retinopathy and diabetic macular edema. Diabetics are considered a vulnerable patient group for cataract surgery, as microincision phacoemulsification (MICS) in diabetics is associated with a higher risk of postoperative swelling of the macula and cornea (macular or corneal edema). In addition, the ultrasound energy emitted during MICS, high and fluctuating intraocular pressure and the movement of surgical instruments and lens material are the main causes of surgical trauma. The medical device "Centurion Vision System" with the "Active Sentry" handpiece was developed specifically to improve the stability of the anterior chamber during surgery and to enable operations at low, almost normal physiological intraocular pressure settings.
The central question of the study is therefore, whether a stable intraocular pressure close to physiological normal conditions (28 mmHg) during surgery can lead to a reduction in surgical trauma. In this prospective and randomized study, patients suffering from diabetes and having a planned bilateral MICS are included in one of two study arms:
- The participant is operated on with an IOP of 28 mm Hg in the better eye and an IOP of 50 mm Hg in the worse eye or B) the participant is operated on with an IOP of 28 mm Hg in the worse eye and an IOP of 50 mm Hg in the better eye.
- Conditions
- Diabetic Retinopathy, Cataract
- Being tested
- Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulation
- Keywords
- Diabetic Retinopathy, Phacoemulsification, Microincision Phacoemulsification, Cataract, Intraocular pressure, Active anterior chamber pressure
- Medical subject headings
- Diabetic Retinopathy, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulationDevice
Cataract surgery in patients with diabetic retinopathy using active anterior chamber pressure sensing and regulation
| Study group | Role | What they receive |
|---|---|---|
| A) IOP 28mmHg on the better eye and IOP 50mmHg on the worse eye | Other | Near normal intraocular pressure cataract surgery using active anterior chamber pressure sensing and regulation Receives: Device: Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulation |
| B) IOP 28mmHg on worse eye and IOP 50mmHg on the better eye | Other | Near normal intraocular pressure cataract surgery using active anterior chamber pressure sensing and regulation Receives: Device: Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta ACF
Difference from pre- to postoperative ACF (delta ACF) at day 1 (FU1) and day 7 (FU2) after cataract surgery.
Measured: 1 week
Secondary outcomes (12)
BCVA
Difference between pre- to postoperative BCVA
Measured: 1 month
5mm corneal volume
Pentacam derived
Measured: 1 month
Anterior chamber depth
Pentacam derived
Measured: 1 month
Mydriatic pupil width
Pentacam derived
Measured: 1 month
Endothelial cell density
Quantifying assessment of endothelial cell loss via specular microscopy; (28 +-3) days after surgery.
Measured: 1 month
Assessment of intraoperative complications
Screening for the presence of posterior capsular ruptures
Measured: 1 month
Assessment of postoperative complications
Presence of cystoid macular edema
Measured: 1 month
Intraoperative events
Assessment of any event in regard to phacoemulsification settings
Measured: Day 0 (Surgery)
Central macular thickness
Pre- and postoperative assessment of central macular thickness via optical coherence tomography (OCT)
Measured: 1 month
Total macular volume
Pre- and postoperative assessment of total macular volume via optical coherence tomography (OCT)
Measured: 1 month
Retinal Nerver fiber layer thickness (RNFL)
Pre- and postoperative assessment of RNFL via optical coherence tomography (OCT)
Measured: 1 month
Central corneal thickness
Pre- and postoperative assessment of central corneal thickness via optical coherence tomography (OCT)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start21 Aug 2024
- Primary completionSep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled randomized, comparative
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617273
- Sponsor's protocol ID
- NNIOP-PHACO
- Acronym
- NNIOP-PHACO
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Normal Intraocular Pressure Cataract Surgery in Patients with Diabetic Retinopathy Using Active Anterior Chamber Pressure Sensing and Regulation - a Randomized Controlled Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06617273
- Acronym / sponsor ID
- NNIOP-PHACO / NNIOP-PHACO
- Conditions
- Diabetic Retinopathy, Cataract
- Keywords
- Diabetic Retinopathy, Phacoemulsification, Microincision Phacoemulsification, Cataract, Intraocular pressure, Active anterior chamber pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 27 Sep 2024 (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.
Diabetes mellitus is a chronic metabolic disease that can lead to visual impairment and eye complications such as diabetic retinopathy and diabetic macular edema. Diabetics are considered a vulnerable patient group for cataract surgery, as microincision phacoemulsification (MICS) in diabetics is associated with a higher risk of postoperative swelling of the macula and cornea (macular or corneal edema). In addition, the ultrasound energy emitted during MICS, high and fluctuating intraocular pressure and the movement of surgical instruments and lens material are the main causes of surgical trauma. The medical device "Centurion Vision System" with the "Active Sentry" handpiece was developed specifically to improve the stability of the anterior chamber during surgery and to enable operations at low, almost normal physiological intraocular pressure settings.
The central question of the study is therefore, whether a stable intraocular pressure close to physiological normal conditions (28 mmHg) during surgery can lead to a reduction in surgical trauma. In this prospective and randomized study, patients suffering from diabetes and having a planned bilateral MICS are included in one of two study arms:
- The participant is operated on with an IOP of 28 mm Hg in the better eye and an IOP of 50 mm Hg in the worse eye or B) the participant is operated on with an IOP of 28 mm Hg in the worse eye and an IOP of 50 mm Hg in the better eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- controlled randomized, comparative
| Arm | Type | Receives |
|---|---|---|
| A) IOP 28mmHg on the better eye and IOP 50mmHg on the worse eye | Other | Device: Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulationNear normal intraocular pressure cataract surgery using active anterior chamber pressure sensing and regulation |
| B) IOP 28mmHg on worse eye and IOP 50mmHg on the better eye | Other | Device: Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulationNear normal intraocular pressure cataract surgery using active anterior chamber pressure sensing and regulation |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Indication for immediate sequential bilateral microincision cataract surgery
- Diagnosis of Diabetes Mellitus treated with oral medication or insulin therapy and confirmed by HbA1c ≥6,5 %
- Presence of diabetic retinopathy grade ≥1 on the international clinical diabetic retinopathy (ICDR) severity scale
- LOCS 2-4 with no more than 1 grade difference between both eyes
- Male or female patient aged 50 - 85 years of age at time of consent
Key exclusion criteria (12 listed)
- Participation in another clinical trial within 30 days before pre-screening and throughout the trial
- Prior intraocular surgery of any type
- History of diabetic macular edema
- Presence of macular edema, defined as central retinal thickness of \>300 µm plus intraretinal or subretinal fluid on OCT within range of 1mm of foveal center
- Presence of any retinal or choroidal disease, other than diabetes, that could affect retinal thickness
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 |
|---|---|---|
| Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulationCataract surgery in patients with diabetic retinopathy using active anterior chamber pressure sensing and regulation | Device | A) IOP 28mmHg on the better eye and IOP 50mmHg on the worse eye, B) IOP 28mmHg on worse eye and IOP 50mmHg on the better eye |
Primary outcome
Delta ACF
Time frame: 1 week
Difference from pre- to postoperative ACF (delta ACF) at day 1 (FU1) and day 7 (FU2) after cataract surgery.
12 secondary outcomes
BCVA
Time frame: 1 month
5mm corneal volume
Time frame: 1 month
Anterior chamber depth
Time frame: 1 month
Mydriatic pupil width
Time frame: 1 month
Endothelial cell density
Time frame: 1 month
Assessment of intraoperative complications
Time frame: 1 month
Assessment of postoperative complications
Time frame: 1 month
Intraoperative events
Time frame: Day 0 (Surgery)
Central macular thickness
Time frame: 1 month
Total macular volume
Time frame: 1 month
Retinal Nerver fiber layer thickness (RNFL)
Time frame: 1 month
Central corneal thickness
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulation in people with Diabetic Retinopathy and Cataract, run by Medical University Innsbruck at 1 site in Austria.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
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?
Delta ACF (time frame: 1 week). 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 27 Sep 2024.