Myopia, High, With Cataract and Anterior Capsule PolishedNCT03142269
The Influences Of Anterior Capsule Polishing On Anterior Capsular Changes and Intraocular Lenses Stability of Super High Myopic Eyes
A study testing 360°anterior capsule polishing in people with Myopia, High, With Cataract and Anterior Capsule Polished, run by yin ying zhao.
Trial summary
A prospective study included 20 patients with super high myopia who underwent bilateral uneventful cataract. 360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye, and the opposite unpolished was used as the control. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, High, With Cataract and Anterior Capsule Polished
- What is being tested?
- 360°anterior capsule polishing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Jul 2016
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:cataract patients with super high myopia (axial length >27mm) and difference of binocular was less than 1mm Exclusion Criteria:larger corneal astigmatism need toric intraocular lens; patients with any systemic or ocular diseases that may influence the anterior capsule opening morphologic, such as keratonosus, glaucoma, uveitis, Pseudoexfoliation syndrome, retinitis pigmentosa and diabetes and Myotonic Dystrophy, etc.; patients with ophthalmic surgery and trauma history.
About this study
Official title: The Influences of 360° Anterior Capsule Polishing on Refraction, Anterior Capsular Opening Size and IOL Stability Among Super High Myopia Patients
A prospective study included 20 patients with super high myopia who underwent bilateral uneventful cataract. 360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye, and the opposite unpolished was used as the control. The refractive state and size of anterior opening were measured at postoperative 1 day as the baseline. Then they followed up at 1 month, 3 months and 6 months after surgery to record refractive state, higher-order aberrations, size of anterior opening, tilt and decentration of IOL (intraocular lenses)and PAD(postoperative aqueous depth). The paired t test was used to compare the differences between the two groups, and the same test the postoperative follow-up comparing with the baseline.
- Being tested
- 360°anterior capsule polishing
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
360°anterior capsule polishingProcedure or surgery
360°anterior capsule polishing was performed with double-ended capsule polisher
| Study group | Role | What they receive |
|---|---|---|
| polished group | Active comparator | 360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye Receives: Procedure: 360°anterior capsule polishing |
| unpolished group | Placebo comparator | the opposite unpolished was used as the control Receives: Procedure: 360°anterior capsule polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
refraction
refractive state
Measured: Change from postoperative 1 day to 1 months
anterior opening size
area,diameter
Measured: Change from postoperative 1 day to 1 months
Stability of IOL
Tilt and Decentration
Measured: Change from postoperative 1 months to 3 months
Secondary outcomes (5)
refraction
refractive state
Measured: Change from postoperative 1 month to 3 months
refraction
refractive state
Measured: Change from postoperative 3 month to 6 months
anterior opening size
area,diameter
Measured: Change from postoperative 1 month to 3 months
anterior opening size
area,diameter
Measured: Change from postoperative 3 month to 6 months
Stability of IOL
Tilt and Decentration
Measured: Change from postoperative 3 month to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Jan 2015
- Primary completion1 Jul 2015
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, High, With Cataract and Anterior Capsule PolishedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- yin ying zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yin ying zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142269
- Sponsor's protocol ID
- kyk201601
- Status last verified
- May 2017
- First submitted
- 25 Feb 2017
- Last updated
- 5 May 2017
- 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 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of 360° Anterior Capsule Polishing on Refraction, Anterior Capsular Opening Size and IOL Stability Among Super High Myopia Patients
- ClinicalTrials.gov ID
- NCT03142269
- Acronym / sponsor ID
- kyk201601
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- yin ying zhaoUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 5 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.
A prospective study included 20 patients with super high myopia who underwent bilateral uneventful cataract. 360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye, and the opposite unpolished was used as the control. The refractive state and size of anterior opening were measured at postoperative 1 day as the baseline. Then they followed up at 1 month, 3 months and 6 months after surgery to record refractive state, higher-order aberrations, size of anterior opening, tilt and decentration of IOL (intraocular lenses)and PAD(postoperative aqueous depth). The paired t test was used to compare the differences between the two groups, and the same test the postoperative follow-up comparing with the baseline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polished group | Active comparator | Procedure: 360°anterior capsule polishing360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye |
| unpolished group | Placebo comparator | Procedure: 360°anterior capsule polishingthe opposite unpolished was used as the control |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 360°anterior capsule polishing360°anterior capsule polishing was performed with double-ended capsule polisher | Procedure or surgery | polished group, unpolished group |
Primary outcome
refraction
Time frame: Change from postoperative 1 day to 1 months
refractive state
anterior opening size
Time frame: Change from postoperative 1 day to 1 months
area,diameter
Stability of IOL
Time frame: Change from postoperative 1 months to 3 months
Tilt and Decentration
5 secondary outcomes
refraction
Time frame: Change from postoperative 1 month to 3 months
refraction
Time frame: Change from postoperative 3 month to 6 months
anterior opening size
Time frame: Change from postoperative 1 month to 3 months
anterior opening size
Time frame: Change from postoperative 3 month to 6 months
Stability of IOL
Time frame: Change from postoperative 3 month to 6 months
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 5 May 2017.
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 360°anterior capsule polishing in people with Myopia, High, With Cataract and Anterior Capsule Polished, run by yin ying zhao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 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. Some participants in this study may receive a placebo. 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?
refraction (time frame: Change from postoperative 1 day to 1 months). The study lists 3 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 5 May 2017.