Endothelial Cell Loss, CornealNCT03855293
Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule
A study testing Rhexis protection shield in people with Endothelial Cell Loss, Corneal, run by Prim. Prof. Dr. Oliver Findl, MBA.
Trial summary
Cataract surgery is one of the most frequently performed surgical procedures worldwide. Since the introduction of phacoemulsification to remove the cataractous lens, risk and complication rates of cataract surgery decreased significantly. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Endothelial Cell Loss, Corneal
- What is being tested?
- Rhexis protection shield
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2016to 5 Apr 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract
- Age 21 and older
- Written informed consent prior to surgery
- Moderate to severe nuclear or mixed cataract
Who cannot join
- Corneal pathologies
- Pregnancy
- Patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome)
About this study
Official title: Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule: a Prospective Randomised Double-masked Study
Cataract surgery is one of the most frequently performed surgical procedures worldwide. Since the introduction of phacoemulsification to remove the cataractous lens, risk and complication rates of cataract surgery decreased significantly.
The phacoemulsification technique utilizes a high-intensity ultrasound energy for the fragmentation and emulsification of the lens. One of the main complications during phacoemulsification, is damaging of the endothelium due to contact with lens fragments of the nucleus following turbulent flow of irrigating solution, resulting in corneal damage, inflammation of the endothelium and corneal edema.
In this study we want to evaluate the effect of the anterior capsule, gained by capsular rhexis, as a corneal shield during phacoemulsification on the corneal endothelium.
- Conditions
- Endothelial Cell Loss, Corneal
- Being tested
- Rhexis protection shield
- Medical subject headings
- Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhexis protection shieldProcedure or surgery
In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | rhexis protection shield Receives: Procedure: Rhexis protection shield |
| Control group | No intervention | regular surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelium cell loss
Comparison of the lost endothelium cells in both groups
Measured: 1 year
Secondary outcomes (1)
central corneal thickness
Comparison of corneal thickness between both groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start2 Mar 2016
- Primary completion1 Apr 2017
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Cell Loss, CornealStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855293
- Sponsor's protocol ID
- Rhexis Protection Shield
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule: a Prospective Randomised Double-masked Study
- ClinicalTrials.gov ID
- NCT03855293
- Acronym / sponsor ID
- Rhexis Protection Shield
- Conditions
- Endothelial Cell Loss, Corneal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 26 Feb 2019 (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.
Cataract surgery is one of the most frequently performed surgical procedures worldwide. Since the introduction of phacoemulsification to remove the cataractous lens, risk and complication rates of cataract surgery decreased significantly.
The phacoemulsification technique utilizes a high-intensity ultrasound energy for the fragmentation and emulsification of the lens. One of the main complications during phacoemulsification, is damaging of the endothelium due to contact with lens fragments of the nucleus following turbulent flow of irrigating solution, resulting in corneal damage, inflammation of the endothelium and corneal edema.
In this study we want to evaluate the effect of the anterior capsule, gained by capsular rhexis, as a corneal shield during phacoemulsification on the corneal endothelium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Procedure: Rhexis protection shieldrhexis protection shield |
| Control group | No intervention | –regular surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cataract
- Age 21 and older
- Written informed consent prior to surgery
- Moderate to severe nuclear or mixed cataract
Key exclusion criteria (3 listed)
- Corneal pathologies
- Pregnancy
- Patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome)
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 |
|---|---|---|
| Rhexis protection shieldIn the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation | Procedure or surgery | Study group |
Primary outcome
endothelium cell loss
Time frame: 1 year
Comparison of the lost endothelium cells in both groups
1 secondary outcome
central corneal thickness
Time frame: 1 year
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 26 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Rhexis protection shield in people with Endothelial Cell Loss, Corneal, run by Prim. Prof. Dr. Oliver Findl, MBA.
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 4 inclusion and 3 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
endothelium cell loss (time frame: 1 year). 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 26 Feb 2019.