AstigmatismNCT02945202
Influence of Trabeculectomy and Phaco-trabeculectomy on Corneal Astigmatism
A study testing Biometry, Refraction and Corneal Topography in people with Astigmatism and Glaucoma, run by University of Zurich.
Trial summary
This study investigates the effects of trabeculectomy and combined phacoemulsification plus trabeculectomy on corneal astigmatism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism, Glaucoma
- What is being tested?
- Biometry, Refraction and Corneal Topography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trabeculectomy or Phaco-Trabeculectomy between 01/2017 and 12/2017
- Age ≥18 years
Who cannot join
- Acute or chronic corneal diseases
About this study
Official title: Einfluss Der Trabekulektomie Und Der Kombinierten Phako-Trabekulektomie Auf Den Kornealen Astigmatismus
This study investigates the effects of trabeculectomy and combined phacoemulsification plus trabeculectomy on corneal astigmatism.
Read the detailed description
Prospectively, consecutive patients at the University Hospital of Zurich undergoing either trabeculectomy (trab) or phaco-trabeculectomy (phaco-trab) are included in this study between January and December 2017. The study interventions takes place 6 months after surgery and include examination of refraction, biometry and corneal topography in order to assess the patient's astigmatism. The values are compared to the preoperative baseline values, which are available from patient records.
- Conditions
- Astigmatism, Glaucoma
- Being tested
- Biometry, Refraction, Corneal Topography
- Medical subject headings
- Astigmatism, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiometryDevice
All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery
RefractionDevice
All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery
Corneal TopographyDevice
All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| All Eyes | Other | All eyes undergo the same interventions. These are the following examinations: Biometry, Refraction and Corneal Topography. The examinations take place 6 months after surgery Receives: Device: Biometry; Device: Refraction; Device: Corneal Topography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Astigmatism [Diopters (dpt)]
Measured: preoperative astigmatism compared to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945202
- Sponsor's protocol ID
- Astigmatismus2017
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Der Trabekulektomie Und Der Kombinierten Phako-Trabekulektomie Auf Den Kornealen Astigmatismus
- ClinicalTrials.gov ID
- NCT02945202
- Acronym / sponsor ID
- Astigmatismus2017
- Conditions
- Astigmatism, Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- 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 study investigates the effects of trabeculectomy and combined phacoemulsification plus trabeculectomy on corneal astigmatism.
Detailed description
Prospectively, consecutive patients at the University Hospital of Zurich undergoing either trabeculectomy (trab) or phaco-trabeculectomy (phaco-trab) are included in this study between January and December 2017. The study interventions takes place 6 months after surgery and include examination of refraction, biometry and corneal topography in order to assess the patient's astigmatism. The values are compared to the preoperative baseline values, which are available from patient records.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Eyes | Other | Device: Biometry, Device: Refraction, Device: Corneal TopographyAll eyes undergo the same interventions. These are the following examinations: Biometry, Refraction and Corneal Topography. The examinations take place 6 months after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Trabeculectomy or Phaco-Trabeculectomy between 01/2017 and 12/2017
- Age ≥18 years
Key exclusion criteria (1 listed)
- Acute or chronic corneal diseases
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 |
|---|---|---|
| BiometryAll patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery | Device | All Eyes |
| RefractionAll patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery | Device | All Eyes |
| Corneal TopographyAll patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery | Device | All Eyes |
Primary outcome
Difference in Astigmatism [Diopters (dpt)]
Time frame: preoperative astigmatism compared to 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Biometry, Refraction and Corneal Topography in people with Astigmatism and Glaucoma, run by University of Zurich.
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 2 inclusion and 1 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 Oct 2016. 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?
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?
Difference in Astigmatism [Diopters (dpt)] (time frame: preoperative astigmatism compared to 6 months postoperatively). 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 Oct 2016.