Corneal AstigmatismNCT03162471
How Astigmatism Influences Corneal Biomechanics and Intraocular Pressure
An observational study of Corneal Astigmatism and Intraocular Pressure, run by Medical University of Lodz.
Trial summary
The aim of the study was to identify whether preoperative corneal astigmatism can influence corneal biomechanics and the assessment of intraocular pressure (IOP) following micro-incision phacoemulsification. Read more about this study
- Who is it for?
- Ages 52 to 90 years
- Conditions the study is for
- Corneal Astigmatism, Intraocular Pressure, Cataract Senile
- What is being tested?
- non-contact measurement of intraocular pressure
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2005to 1 Dec 2016
- 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 52 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 39 patients diagnosed with cataracts were enrolled in the study
Who may be able to join
- diagnosis and qualification for cataract surgery, corneal astigmatism of equal to or less than 2.25 Dcyl
Who cannot join
- corneal astigmatism higher than 2.25 Dcyl, history of any other corneal disease (infection, trauma, ulceration, autoimmune inflammation, Fuchs Dystrophy, keratoconus, corneal scars, preoperative insufficiency of corneal endothelium), glaucoma and chronic use of non-glaucoma eye drops, blepharitis, dry eye, use of contact lenses diabetes or a history of corneal refractive surgery
About this study
Official title: Impact of Preoperative Astigmatism on Corneal Biomechanics and Accurate Intraocular Pressure Measurement After Micro-incision Phacoemulsification
The aim of the study was to identify whether preoperative corneal astigmatism can influence corneal biomechanics and the assessment of intraocular pressure (IOP) following micro-incision phacoemulsification.
- Conditions
- Corneal Astigmatism, Intraocular Pressure, Cataract Senile
- Being tested
- non-contact measurement of intraocular pressure
- Keywords
- Corneal astigmatism, Cataract surgery, Corneal hysteresis, Corneal resistance factor, Intraocular pressure
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-contact measurement of intraocular pressureDiagnostic test
Non-contact measurement of corneal biomechanical properties and intraocular pressure with an Ocular Response Analyzer. Parameters measured: corneal hysteresis (CH), corneal resistance factor (CRF), Goldman-correlated IOP (IOPg), corneal compensated IOP (IOPcc) and waveform score (WS).
What is being measured
The primary outcome is the main question the study is designed to answer.
change of corneal compensated IOP (IOPcc)
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Measured: Parameter measured preoperatively and one day, one week, one month postoperatively
Secondary outcomes (4)
change of corneal hysteresis (CH)
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Measured: Parameter measured preoperatively and one day, one week, one month postoperatively
change of corneal resistance factor (CRF)
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Measured: Parameter measured preoperatively and one day, one week, one month postoperatively
change of Goldman-correlated IOP (IOPg)
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Measured: Parameter measured preoperatively and one day, one week, one month postoperatively
change of waveform score (WS)
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
Measured: Parameter measured preoperatively and one day, one week, one month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 May 2005
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal AstigmatismStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zofia Pniakowska, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162471
- Sponsor's protocol ID
- RNN/166/17/KE
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 22 May 2017
- 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 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Astigmatism on Corneal Biomechanics and Accurate Intraocular Pressure Measurement After Micro-incision Phacoemulsification
- ClinicalTrials.gov ID
- NCT03162471
- Acronym / sponsor ID
- RNN/166/17/KE
- Conditions
- Corneal Astigmatism, Intraocular Pressure, Cataract Senile
- Keywords
- Corneal astigmatism, Cataract surgery, Corneal hysteresis, Corneal resistance factor, Intraocular pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 May 2005 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 22 May 2017 (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.
The aim of the study was to identify whether preoperative corneal astigmatism can influence corneal biomechanics and the assessment of intraocular pressure (IOP) following micro-incision phacoemulsification.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 52 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 39 patients diagnosed with cataracts were enrolled in the study
Key inclusion criteria (1 listed)
- diagnosis and qualification for cataract surgery, corneal astigmatism of equal to or less than 2.25 Dcyl
Key exclusion criteria (1 listed)
- corneal astigmatism higher than 2.25 Dcyl, history of any other corneal disease (infection, trauma, ulceration, autoimmune inflammation, Fuchs Dystrophy, keratoconus, corneal scars, preoperative insufficiency of corneal endothelium), glaucoma and chronic use of non-glaucoma eye drops, blepharitis, dry eye, use of contact lenses diabetes or a history of corneal refractive surgery
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 |
|---|---|---|
| non-contact measurement of intraocular pressureNon-contact measurement of corneal biomechanical properties and intraocular pressure with an Ocular Response Analyzer. Parameters measured: corneal hysteresis (CH), corneal resistance factor (CRF), Goldman-correlated IOP (IOPg), corneal compensated IOP (IOPcc) and waveform score (WS). | Diagnostic test | – |
Primary outcome
change of corneal compensated IOP (IOPcc)
Time frame: Parameter measured preoperatively and one day, one week, one month postoperatively
Intraocular pressure and corneal biomechanical properties were measured using an Ocular Response Analyzer.
4 secondary outcomes
change of corneal hysteresis (CH)
Time frame: Parameter measured preoperatively and one day, one week, one month postoperatively
change of corneal resistance factor (CRF)
Time frame: Parameter measured preoperatively and one day, one week, one month postoperatively
change of Goldman-correlated IOP (IOPg)
Time frame: Parameter measured preoperatively and one day, one week, one month postoperatively
change of waveform score (WS)
Time frame: Parameter measured preoperatively and one day, one week, one month postoperatively
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 22 May 2017.
- 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?
An observational study of Corneal Astigmatism and Intraocular Pressure, run by Medical University of Lodz.
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 1 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: finished, as of the sponsor's last update on 22 May 2017. 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?
change of corneal compensated IOP (IOPcc) (time frame: Parameter measured preoperatively and one day, one week, one month 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 22 May 2017.