Prospective, controlled, randomized, monocentric clinical investigation of performance and safety of Pro-ophta® Ocular Sticks in comparison with an alternative device
Organizational Data
- DRKS-ID:
- DRKS00025690
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-11-16
- Last update in DRKS:
- 2024-02-07
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Comparation study to evaluate the performance, safety and usability of the device Pro-ophta® Ocular Sticks and BVI Visitec® Absorbent Stick devices.
Brief summary in scientific language
Prospective, controlled, randomized, monocentric comparison study. The performance, safety and usability of the device Pro-ophta® Ocular Sticks and BVI Visitec® Absorbent Stick devices will be evaluated and compared. Patients, requiring an eye surgery, will be included and randomly divid-ed in two equal groups, with Pro-ophta® Ocular Sticks used during ocular surgery for one group and BVI Visitec® Absorbent Stick device for another. Only one visit (surgery day) is planned for each patient. No follow up is planned for this study.
Health condition or problem studied
- ICD10:
- H00-H59 - Diseases of the eye and adnexa
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Pro-ophta® Ocular Sticks
- Arm 2:
- BVI Visitec® Absorbent Stick
Endpoints
- Primary outcome:
- Performance of the product, measured by level of satisfaction of the surgeon
- Secondary outcome:
- Frequency and severity of device-related adverse events and incidents
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Augentagesklinik am Spreebogen Berlin
Recruitment period and number of participants
- Planned study start date:
- 2021-12-31
- Actual study start date:
- 2022-02-11
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-02-28
- Target Sample Size:
- 108
- Final Sample Size:
- 106
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Age ≥ 18 years Patient is legally capable Ophthalmology surgery is performed for a patient Patient has signed a written Informed Consent
Exclusion Criteria
Known intolerability to the product Participation in other clinical study within 30 days for the study entry and during the study Patient not covered by health insurance/social security
Addresses
Primary Sponsor
- Address:
- Lohmann & Rauscher GmbH & Co. KGAngela OdameIrlicher Str. 5556567 NeuwiedGermany
- Telephone:
- +49 (0) 2631 99 6455
- Fax:
- 49 (0) 2631 99 1455
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.lohmann-rauscher.com/de-de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Augentagesklinik am SpreebogenDr. Prof. Manfred R. TetzAlt-Moabit 101 B10559 BerlinGermany
- Telephone:
- +49(30) 398098 – 0
- Fax:
- +49(30) 398098 – 44
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.augentagesklinik-spreebogen.de
Contact for Public Queries
- Address:
- Augentagesklinik am SpreebogenStefanie KönigAlt-Moabit 101 B10559 BerlinGermany
- Telephone:
- 10117
- Fax:
- +49(30) 398098 – 0
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.augentagesklinik-spreebogen.de
Principal Investigator
- Address:
- Augentagesklinik am SpreebogenDr. Prof. Manfred R. TetzAlt-Moabit 101 B10559 BerlinGermany
- Telephone:
- +49(30) 398098 – 0
- Fax:
- +49(30) 398098 – 44
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.augentagesklinik-spreebogen.de
Other contact for public queries
- Address:
- Lohmann & Rauscher GmbH & Co. KGDr Martin AbelIrlicher Straße 5556567 NeuwiedGermany
- Telephone:
- +49 (0) 2631 99 6566
- Fax:
- +49 (0) 2631 99 1566
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.lohmann-rauscher.com/de-de/
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Lohmann & Rauscher GmbH & Co. KGIrlicher Str. 5556567 NeuwiedGermany
- Telephone:
- +49 2631 99-6566
- Fax:
- +49 2631 99-1566
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.lohmann-rauscher.com/de-de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer BerlinFriedrichstraße 1610696 BerlinGermany
- Telephone:
- (+49)30-408062601
- Fax:
- (+49)30-408062298
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-08-19
- Ethics committee number:
- Eth-57/21
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-09-28
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- Q2 2024
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- 106 patients (Pro-ophta® Ocular Stick , n = 53 and alternative device, n = 53) were included in the analyses. In both treatment groups, the investigator ́s/surgeon’s general user satisfaction was rated as either “good” or “very good”. The non-inferior hypothesis that the Pro-ophta® Ocular Stick is not rated worse in satisfaction than the alternative device was confirmed. Better/ higher judgement/satisfaction was observed when using the Pro-ophta® Ocular Stick and this effect was statistically significant (p = 0.0005). No device-related adverse event occurred. At least 98.12% were rated as “good” and “very good” in both treatment groups for the additional endpoints. No additional endpoint was rated worse than "rather good/satisfactory" (score of 3) on the 6-point Likert scale. However, better assessments were recorded when using Pro-ophta® Ocular Stick regarding all the additional endpoints except one: usage convenience (removal of foreign matter / dissecting out) with comparable evaluation in both treatment groups.