Intraocular Lens ComplicationNCT03761745
Rotational Stability of Different Intraocular Lenses in The Capsular Bag
An observational study of Intraocular Lens Complication and Phacoemulsification, run by Wenzhou Medical University at 1 site in China.
Trial summary
To evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Lens Complication, Phacoemulsification
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2018to 30 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received Femtosecond laser-assisted phacoemulsification surgery in The Eye Hospital of Wenzhou Medical University
Who may be able to join
- Age ≥ 18 years
- Patients who had received Femtosecond laser-assisted phacoemulsification surgery with IntelliAxis-L capsular mark.
- The operation was smooth and there were no surgical complications.
Who cannot join
- Corneal and other ocular diseases (such as corneal opacity, keratitis, glaucoma, uveitis, lens dislocation or subluxation, lens capsule relaxation, retinopathy, etc.);
- History of ocular trauma or surgery before this cataract surgery;
- intraoperative and postoperative complications, such as posterior capsule rupture, corneal endothelium decompensation;
- Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), blood, mental dysfunction and other diseases affect the results of this study;
Trial locations and contacts
1 site in 1 country.
China1 site
Eye Hispital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
To evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery.
- Conditions
- Intraocular Lens Complication, Phacoemulsification
- Keywords
- Rotation, Postoperative Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment of intraocular lens
The alignment of intraocular lens was evaluated by anterior segment photography
Measured: 1 day postoperatively
Alignment of intraocular lens
The alignment of intraocular lens was evaluated by anterior segment photography
Measured: 1 week postoperatively
Alignment of intraocular lens
The alignment of intraocular lens was evaluated by anterior segment photography
Measured: 1 month, postoperatively
Secondary outcomes (3)
Intraocular Pressure
Intraocular Pressure measured by non-contact tonometers
Measured: 1 day, 1 week, 1 month, postoperatively
Corrected Visual Acuity (UCVA) at Distance
UCVA was determined by subjective refraction
Measured: 1 day, 1 week, 1 month, postoperatively
Uncorrected Visual Acuity (UCVA) at Distance
Measured: 1 day, 1 week, 1 month, postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start29 Dec 2018
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Lens ComplicationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A-Yong Yu, Wenzhou Medical University
- Investigators
- AYong Yu, MD.PhD., Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761745
- Sponsor's protocol ID
- 2018Rotation
- Status last verified
- Mar 2025
- First submitted
- 26 Nov 2018
- Last updated
- 28 Mar 2025
- 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Stability of Different Intraocular Lenses in The Capsular Bag
- ClinicalTrials.gov ID
- NCT03761745
- Acronym / sponsor ID
- 2018Rotation
- Conditions
- Intraocular Lens Complication, Phacoemulsification
- Keywords
- Rotation, Postoperative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 29 Dec 2018 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 3 Dec 2018 (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.
To evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received Femtosecond laser-assisted phacoemulsification surgery in The Eye Hospital of Wenzhou Medical University
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients who had received Femtosecond laser-assisted phacoemulsification surgery with IntelliAxis-L capsular mark.
- The operation was smooth and there were no surgical complications.
Key exclusion criteria (4 listed)
- Corneal and other ocular diseases (such as corneal opacity, keratitis, glaucoma, uveitis, lens dislocation or subluxation, lens capsule relaxation, retinopathy, etc.);
- History of ocular trauma or surgery before this cataract surgery;
- intraoperative and postoperative complications, such as posterior capsule rupture, corneal endothelium decompensation;
- Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), blood, mental dysfunction and other diseases affect the results of this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alignment of intraocular lens
Time frame: 1 day postoperatively
The alignment of intraocular lens was evaluated by anterior segment photography
Alignment of intraocular lens
Time frame: 1 week postoperatively
The alignment of intraocular lens was evaluated by anterior segment photography
Alignment of intraocular lens
Time frame: 1 month, postoperatively
The alignment of intraocular lens was evaluated by anterior segment photography
3 secondary outcomes
Intraocular Pressure
Time frame: 1 day, 1 week, 1 month, postoperatively
Corrected Visual Acuity (UCVA) at Distance
Time frame: 1 day, 1 week, 1 month, postoperatively
Uncorrected Visual Acuity (UCVA) at Distance
Time frame: 1 day, 1 week, 1 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 28 Mar 2025.
- 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.
AYong Yu, MD.PhD. principal investigator
Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Lens Complication and Phacoemulsification, run by Wenzhou Medical University 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 3 inclusion and 4 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 28 Mar 2025. 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.
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?
Alignment of intraocular lens (time frame: 1 day postoperatively). 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 28 Mar 2025.