Cataract SurgeryNCT03644875
Study of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
An observational study of Cataract Surgery, run by Croma-Pharma GmbH at 1 site in Austria.
Trial summary
This is a prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etacoat in patients undergoing cataract surgery. The performance is evaluated by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- etacoat
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 28 Jun 2018to 16 May 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study patients will be recruited by the investigator, among patients scheduled to receive a standard cataract surgery taking inclusion and exclusion criteria into account. The investigator may also offer participation in the study to potential candidates identified in their patient database.
Who may be able to join
- Patients indicated for cataract surgery via the anterior chamber
- A negative urine pregnany test at Visit 1 or 2
- Capability to understand information about the investigation, including patients' obligations, and willingness to take part, as evidenced by signed and dated informed consent.
Who cannot join
- Patient who are known to be hypersensitive to HPMC or other components of the device
- Patients with corneal scars or corneal dystrophies interfering with study measurements
- Abnormal intraocular pressure which would interfere with surgery and follow up (in opinion of the investigator)
- Any other condition that in the opinion of the investigator would interfere with the participation in this investigation
- Any person dependent on the investigator or employees of the investigation site institution or the Sponsor
- Current or previous (within 30 days of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study
- Patients whose participation in clinical trials is prohibited by the Austrian Medical Devices Act
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
Vienna
About this study
Official title: A Prospective, Single Center, Non-comparative, 90-Day Follow-up, Postmarket Clinical Investigation of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
This is a prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etacoat in patients undergoing cataract surgery.
The performance is evaluated by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.
- Conditions
- Cataract Surgery
- Being tested
- etacoat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etacoatDevice
Etacoat is a HPMC formulation intended to be used in ophthalmic anterior segment cataract surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Specular microscopy to measure the preservation of endothelium
Measured: 90 days post surgery compared to baseline
Secondary outcomes (3)
Specular microscopy to measure the corneal thickness
Measured: post surgery, 1 day and 90 days post surgery compared to baseline
Intraocular pressure measurement
Measured: post surgery, 1 day and 90 days post surgery compared to baseline
Questionnaire to assess the satisfaction with the application
Questionnaire contains the subjective evaluation by the investigator of the IMD's rheological properties as well as the maintenance of the patient's anterior chamber and dome.
Scale for the chamber and dome maintenance ranges from flat (worst case) to full chamber (best case) maintained.
Scale for rheological properties ranges from dispersive (best case) to cohesive (worst case).
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start28 Jun 2018
- Primary completion16 May 2019
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644875
- Sponsor's protocol ID
- CPH-401-201287
- Status last verified
- Dec 2024
- First submitted
- 9 Aug 2018
- Last updated
- 10 Dec 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Non-comparative, 90-Day Follow-up, Postmarket Clinical Investigation of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
- ClinicalTrials.gov ID
- NCT03644875
- Acronym / sponsor ID
- CPH-401-201287
- Conditions
- Cataract Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 23 Aug 2018 (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.
This is a prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etacoat in patients undergoing cataract surgery.
The performance is evaluated by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study patients will be recruited by the investigator, among patients scheduled to receive a standard cataract surgery taking inclusion and exclusion criteria into account. The investigator may also offer participation in the study to potential candidates identified in their patient database.
Key inclusion criteria (3 listed)
- Patients indicated for cataract surgery via the anterior chamber
- A negative urine pregnany test at Visit 1 or 2
- Capability to understand information about the investigation, including patients' obligations, and willingness to take part, as evidenced by signed and dated informed consent.
Key exclusion criteria (7 listed)
- Patient who are known to be hypersensitive to HPMC or other components of the device
- Patients with corneal scars or corneal dystrophies interfering with study measurements
- Abnormal intraocular pressure which would interfere with surgery and follow up (in opinion of the investigator)
- Any other condition that in the opinion of the investigator would interfere with the participation in this investigation
- Any person dependent on the investigator or employees of the investigation site institution or the Sponsor
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 |
|---|---|---|
| etacoatEtacoat is a HPMC formulation intended to be used in ophthalmic anterior segment cataract surgery. | Device | – |
Primary outcome
Specular microscopy to measure the preservation of endothelium
Time frame: 90 days post surgery compared to baseline
3 secondary outcomes
Specular microscopy to measure the corneal thickness
Time frame: post surgery, 1 day and 90 days post surgery compared to baseline
Intraocular pressure measurement
Time frame: post surgery, 1 day and 90 days post surgery compared to baseline
Questionnaire to assess the satisfaction with the application
Time frame: day 0
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 10 Dec 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?
An observational study of Cataract Surgery, run by Croma-Pharma GmbH 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 3 inclusion and 7 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 10 Dec 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?
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?
Specular microscopy to measure the preservation of endothelium (time frame: 90 days post surgery compared to baseline). 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 10 Dec 2024.