AstigmatismPhase 4NCT01554761
Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
A Phase 4 study testing phacoemulsification and Pentacam (Oculus,Germany)examination in people with Astigmatism and Cataract, run by China Medical University, China at 1 site in China.
Trial summary
This study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Astigmatism, Cataract
- What is being tested?
- phacoemulsification and Pentacam (Oculus,Germany)examination
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to May 2012
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cataract candidates
- preoperative corneal regular astigmatism >0.75D
- Willing and able to complete all required postoperative visits
- Able to comprehend and sign a statement of informed consent
Who cannot join
- significant intraocular lenses tilt or decentration
- corneal scarring
- Irregular corneal astigmatism
- other ocular diseases
- surgical complication
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye hospital of China Medical Univerisity
Shenyang, Liaoning, 110005
Jinsong Zhang, MD, +86 13066667486
Qi Sun, MD
About this study
This study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses.
This is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.
- Conditions
- Astigmatism, Cataract
- Being tested
- phacoemulsification, Pentacam (Oculus,Germany)examination
- Keywords
- astigmatism, pseudophakia
- Medical subject headings
- Astigmatism, Cataract, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsificationProcedure or surgery
After topical anesthesia with Alcaine, 3.0-mm clear corneal incisions were made. Torsional phacoemulsification was performed using the Infiniti Vision System with the OZil handpiece, a 45-degree Kelman miniflared tip, and DuoVisc viscoelastic (all from Alcon).
Pentacam (Oculus,Germany)examinationDevice
Total corneal astigmatism is obtained by Pentacam at every visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pentacam-derived corneal astigmatism
Measured: 3month postoperatively
refraction
Measured: 3month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsong Zhang, China Medical University, China
- Investigators
- Jinsong Zhang, MD, Principal investigator, Eye Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554761
- Sponsor's protocol ID
- 2
- Status last verified
- Mar 2012
- First submitted
- 27 Feb 2012
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
- ClinicalTrials.gov ID
- NCT01554761
- Acronym / sponsor ID
- 2
- Conditions
- Astigmatism, Cataract
- Keywords
- astigmatism, pseudophakia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2012 (estimated)
- First posted
- 15 Mar 2012 (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 is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses.
This is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cataract candidates
- preoperative corneal regular astigmatism >0.75D
- Willing and able to complete all required postoperative visits
- Able to comprehend and sign a statement of informed consent
Key exclusion criteria (5 listed)
- significant intraocular lenses tilt or decentration
- corneal scarring
- Irregular corneal astigmatism
- other ocular diseases
- surgical complication
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 |
|---|---|---|
| phacoemulsificationAfter topical anesthesia with Alcaine, 3.0-mm clear corneal incisions were made. Torsional phacoemulsification was performed using the Infiniti Vision System with the OZil handpiece, a 45-degree Kelman miniflared tip, and DuoVisc viscoelastic (all from Alcon). | Procedure or surgery | – |
| Pentacam (Oculus,Germany)examinationTotal corneal astigmatism is obtained by Pentacam at every visit. | Device | – |
Primary outcome
Pentacam-derived corneal astigmatism
Time frame: 3month postoperatively
refraction
Time frame: 3month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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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.
Jinsong Zhang, MD principal investigator
Eye Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing phacoemulsification and Pentacam (Oculus,Germany)examination in people with Astigmatism and Cataract, run by China Medical University, China at 1 site in China.
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 5 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 15 Mar 2012. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Qi Sun, MD (+86 15840336028, qisun97@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pentacam-derived corneal astigmatism (time frame: 3month postoperatively). The study lists 2 primary outcomes in all. 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 15 Mar 2012.