Age-related CataractNCT05148741
Evaluation of Capsular Bag Shape Changes After Plate-haptic Intraocular Lens Implantation by SS-OCT
An observational study of Age-related Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
Evaluation of capsular bag shape changes after plate-haptic intraocular lens implantation by SS-OCT. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Age-related Cataract
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Jul 2021
- How long will I take part?
- 3 Months
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: The patients were divided into 2 groups according to the different intraocular lenses implanted: 39 eyes were implanted with the C-loop haptic intraocular lens (Acrysof) while the other 41 eyes were implanted with plate haptic intraocular lenses (CT ASPHINA 509 M).
Who may be able to join
- -patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.
Who cannot join
- people cannot cooperate with the check， corneal opacity, glaucoma, and other eye diseases
- any other previous intraocular surgery, and intraoperative complications including anterior or posterior capsulartears
- Continuous circular capsulorhexis is not centered and Mydriasis is less than 7mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Capsular Bag Shape Changes After Plate-haptic Intraocular Lens Implantation by SS-OCT.
Evaluation of capsular bag shape changes after plate-haptic intraocular lens implantation by SS-OCT.
Read the detailed description
Eighty patients (80 eyes) with simple age-related cataracts were treated from December 2019 to December 2020 in the Wenzhou Medical University. Investigators specifically included patients who were bodily healthy and underwent a successful implantation of an IOL. Inclusion criteria for this study were patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.
- Conditions
- Age-related Cataract
- Keywords
- SS-OCT, capsule bag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | implanted with the C-loop haptic intraocular lens | |
| Group 2 | implanted with the plate haptic intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsular bend index (CBI)
capsule bend formation has 5 continuous stages from 0 to 4，The stage score varies over different positions of the same capsule bag, because the capsule bend formation is inconsistent along the entire optic edge. CBI is the mean of the different stage scores in different positions and represents the general capsule bend state of the whole capsule bag.
Measured: 2020.12.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jul 2020
- Primary completion1 Dec 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related CataractStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- Yune Zhao, Study director, Ophthalmology and Optometry Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148741
- Sponsor's protocol ID
- SS-OCT plate-haptic
- Status last verified
- Dec 2021
- First submitted
- 14 Sep 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Capsular Bag Shape Changes After Plate-haptic Intraocular Lens Implantation by SS-OCT.
- ClinicalTrials.gov ID
- NCT05148741
- Acronym / sponsor ID
- SS-OCT plate-haptic
- Conditions
- Age-related Cataract
- Keywords
- SS-OCT, capsule bag
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 8 Dec 2021 (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.
Evaluation of capsular bag shape changes after plate-haptic intraocular lens implantation by SS-OCT.
Detailed description
Eighty patients (80 eyes) with simple age-related cataracts were treated from December 2019 to December 2020 in the Wenzhou Medical University. Investigators specifically included patients who were bodily healthy and underwent a successful implantation of an IOL. Inclusion criteria for this study were patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –implanted with the C-loop haptic intraocular lens |
| Group 2 | – | –implanted with the plate haptic intraocular lens |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients were divided into 2 groups according to the different intraocular lenses implanted: 39 eyes were implanted with the C-loop haptic intraocular lens (Acrysof) while the other 41 eyes were implanted with plate haptic intraocular lenses (CT ASPHINA 509 M).
Key inclusion criteria (1 listed)
- -patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.
Key exclusion criteria (3 listed)
- people cannot cooperate with the check， corneal opacity, glaucoma, and other eye diseases
- any other previous intraocular surgery, and intraoperative complications including anterior or posterior capsulartears
- Continuous circular capsulorhexis is not centered and Mydriasis is less than 7mm.
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
Capsular bend index (CBI)
Time frame: 2020.12.1
capsule bend formation has 5 continuous stages from 0 to 4，The stage score varies over different positions of the same capsule bag, because the capsule bend formation is inconsistent along the entire optic edge. CBI is the mean of the different stage scores in different positions and represents the general capsule bend state of the whole capsule bag.
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 8 Dec 2021.
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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.
Yune Zhao study director
Ophthalmology and Optometry Hospital
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 Age-related Cataract, 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 1 inclusion and 3 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 8 Dec 2021. 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?
Capsular bend index (CBI) (time frame: 2020.12.1). 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 8 Dec 2021.