High MyopiaNCT07052825
The Role of Capsular Tension Rings in Intraocular Lens Stability in High Myopia Cataract Patients: A Prospective Self-Controlled Study
A study testing CTR implantation in people with High Myopia and Cataract, run by Jin Yang at 1 site in China.
Trial summary
Study Purpose: This prospective, self-controlled clinical study aims to evaluate the impact of capsular tension rings (CTR) on intraocular lens (IOL) stability in high myopia patients undergoing bilateral cataract surgery. Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- High Myopia, Cataract
- What is being tested?
- CTR implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosed with bilateral age-related cataracts and scheduled for phacoemulsification with IOL implantation in both eyes.
- High myopia in both eyes, defined as axial length (AL) ≥ 26.0 mm.
- No significant difference in axial length between the two eyes (e.g., interocular AL difference < 1.0 mm).
- Willingness and ability to undergo bilateral surgery within a short interval (e.g., within 1-2 weeks).
- Able to provide informed consent and comply with the study protocol and follow-up visits.
Who cannot join
- History of ocular trauma, surgery, or intraocular inflammation in either eye.
- Presence of other ocular diseases that may affect visual outcomes, such as glaucoma, diabetic retinopathy, macular degeneration, or corneal opacity.
- Evidence of zonular weakness, pseudoexfoliation, or significant phacodonesis preoperatively.
- Severe dry eye or poor fixation that may interfere with postoperative imaging.
- Systemic diseases affecting visual function (e.g., uncontrolled diabetes, neurologic disorders).
- Participation in other clinical trials that may affect the study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Baoxian Zhuo contact
China1 site, 1 recruiting
- Recruiting
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Xuanqiao Lin, 15088920668, 1532483480@qq.com
About this study
Study Purpose:
This prospective, self-controlled clinical study aims to evaluate the impact of capsular tension rings (CTR) on intraocular lens (IOL) stability in high myopia patients undergoing bilateral cataract surgery. Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, refraction, IOL positioning, and visual quality, will be compared between eyes to assess the effectiveness of CTR.
Read more
Study Methods:
Eligible participants (axial length ≥ 26.0 mm) will undergo femtosecond-assisted phacoemulsification with identical IOLs implanted in both eyes. One eye will be randomly assigned to receive a CTR. All surgeries will be performed by the same surgeon. Follow-up will be conducted at 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively. Assessments will include UCVA, BCVA, refractive error, anterior segment OCT, IOL decentration and tilt, and visual quality (iTrace).
Sample Size and Population:
A total of 60 patients (120 eyes) will be enrolled. Inclusion criteria include age ≥ 18 years and bilateral cataracts with high myopia. Exclusion criteria include other ocular diseases, history of severe ocular trauma, or poor visual potential. Patients will be stratified by axial length into three groups: ≤28 mm, 28-30 mm, and >30 mm.
Study Procedure:
After informed consent and baseline examinations (including ocular biometry and imaging), patients will undergo surgery and be followed at specified intervals. All data will be managed securely. Comparative analysis between CTR and non-CTR eyes will be performed to evaluate the effect of CTR on IOL stability and visual outcomes in highly myopic cataract patients.
Read the detailed description
Study Purpose:
This study aims to evaluate the effect of capsular tension rings (CTR) on intraocular lens (IOL) stability in cataract patients with high myopia. Each patient will undergo cataract surgery in both eyes, with one eye receiving a CTR and the other eye not receiving a CTR, using the same IOL model in both eyes. Postoperative visual quality and IOL stability will be compared between the two eyes. The study will analyze changes in postoperative visual acuity, refraction, ocular parameters, anterior segment morphology, and IOL positioning to assess the effect of CTR implantation on visual outcomes in highly myopic patients.
Study Methods:
This is a prospective, self-controlled clinical study involving cataract patients with high myopia (axial length ≥ 26.0 mm) scheduled for bilateral cataract surgery. Patients will undergo femtosecond-assisted phacoemulsification and IOL implantation in both eyes, with one eye randomly assigned to receive a CTR and the other not. All procedures will be performed by the same surgeon to ensure consistency. Postoperative follow-up visits will be scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months. Evaluation indicators include uncorrected and best corrected visual acuity (UCVA, BCVA), refractive status, intraocular pressure, anterior segment morphology (anterior segment OCT), IOL decentration and tilt (using anterior segment images), and visual quality (iTrace).
Sample Size and Study Population:
The estimated sample size is 60 patients (i.e., 120 eyes). Each patient will receive CTR implantation in one eye and serve as their own control in the fellow eye. Inclusion criteria: age ≥ 18 years, bilateral cataracts with high myopia eligible for surgery. Exclusion criteria: ocular comorbidities (e.g., glaucoma, retinal disease), history of major ocular trauma or surgery, and other causes of vision loss. Patients will be grouped based on axial length: Group A (AL ≤ 28 mm), Group B (28 mm < AL ≤ 30 mm), and Group C (AL > 30 mm).
Study Procedure:
Participants will be recruited after signing informed consent and passing pre-screening assessments. All subjects will receive detailed explanations regarding study purpose, procedures, risks, and postoperative care. Baseline examinations will include biometry, axial length, anterior segment measurements, and corneal topography. After surgery, patients will be followed up at 1 day, 1 week, 1 month, 3 months, and 6 months. Examinations include visual acuity, refraction, intraocular pressure, IOL position (decentration and tilt via anterior segment OCT), and visual quality analysis (iTrace). All data will be securely managed, and the final analysis will compare visual outcomes and IOL stability between the CTR and non-CTR eyes in highly myopic patients.
- Conditions
- High Myopia, Cataract
- Being tested
- CTR implantation
- Keywords
- Capsular Tension Ring（CTR）, High Myopia, Intraocular lens, Tilt, Decentration, Visual Quality
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTR implantationProcedure or surgery
Phaco+IOL with CTR implantation
| Study group | Role | What they receive |
|---|---|---|
| CTR implantation | Experimental | Phaco+IOL with CTR implantation Receives: Procedure: CTR implantation |
| NCTR | No intervention | Phaco+IOL without CTR implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilt and Decentration
measured by using anterior segment OCT
Measured: Postoperative follow-up visits will be scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months
Secondary outcomes (3)
Anterior Capsular Contraction
Measured by Anterior Segment Photography and ImageJ
Measured: 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively
visual acuity
UDVA AND BCVA
Measured: 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively
Visual Quality
Measured by iTace
Measured: 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a self-controlled study. Each participant receives cataract surgery in both eyes, with one eye randomly assigned to CTR implantation and the fellow eye without CTR. The two eyes serve as within-subject comparators.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Yang, Eye & ENT Hospital of Fudan University
- Investigators
- Jin Yang, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052825
- Sponsor's protocol ID
- HM CTR
- Other IDs
- 82171039
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 7 Jul 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 7 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Capsular Tension Rings in Intraocular Lens Stability in High Myopia Cataract Patients: A Prospective Self-Controlled Study
- ClinicalTrials.gov ID
- NCT07052825
- Acronym / sponsor ID
- HM CTR
- Conditions
- High Myopia, Cataract
- Keywords
- Capsular Tension Ring（CTR）, High Myopia, Intraocular lens, Tilt, Decentration, Visual Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jin YangUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Jul 2025 (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.
Study Purpose:
This prospective, self-controlled clinical study aims to evaluate the impact of capsular tension rings (CTR) on intraocular lens (IOL) stability in high myopia patients undergoing bilateral cataract surgery. Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, refraction, IOL positioning, and visual quality, will be compared between eyes to assess the effectiveness of CTR.
Study Methods:
Eligible participants (axial length ≥ 26.0 mm) will undergo femtosecond-assisted phacoemulsification with identical IOLs implanted in both eyes. One eye will be randomly assigned to receive a CTR. All surgeries will be performed by the same surgeon. Follow-up will be conducted at 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively. Assessments will include UCVA, BCVA, refractive error, anterior segment OCT, IOL decentration and tilt, and visual quality (iTrace).
Sample Size and Population:
A total of 60 patients (120 eyes) will be enrolled. Inclusion criteria include age ≥ 18 years and bilateral cataracts with high myopia. Exclusion criteria include other ocular diseases, history of severe ocular trauma, or poor visual potential. Patients will be stratified by axial length into three groups: ≤28 mm, 28-30 mm, and >30 mm.
Study Procedure:
After informed consent and baseline examinations (including ocular biometry and imaging), patients will undergo surgery and be followed at specified intervals. All data will be managed securely. Comparative analysis between CTR and non-CTR eyes will be performed to evaluate the effect of CTR on IOL stability and visual outcomes in highly myopic cataract patients.
Detailed description
Study Purpose:
This study aims to evaluate the effect of capsular tension rings (CTR) on intraocular lens (IOL) stability in cataract patients with high myopia. Each patient will undergo cataract surgery in both eyes, with one eye receiving a CTR and the other eye not receiving a CTR, using the same IOL model in both eyes. Postoperative visual quality and IOL stability will be compared between the two eyes. The study will analyze changes in postoperative visual acuity, refraction, ocular parameters, anterior segment morphology, and IOL positioning to assess the effect of CTR implantation on visual outcomes in highly myopic patients.
Study Methods:
This is a prospective, self-controlled clinical study involving cataract patients with high myopia (axial length ≥ 26.0 mm) scheduled for bilateral cataract surgery. Patients will undergo femtosecond-assisted phacoemulsification and IOL implantation in both eyes, with one eye randomly assigned to receive a CTR and the other not. All procedures will be performed by the same surgeon to ensure consistency. Postoperative follow-up visits will be scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months. Evaluation indicators include uncorrected and best corrected visual acuity (UCVA, BCVA), refractive status, intraocular pressure, anterior segment morphology (anterior segment OCT), IOL decentration and tilt (using anterior segment images), and visual quality (iTrace).
Sample Size and Study Population:
The estimated sample size is 60 patients (i.e., 120 eyes). Each patient will receive CTR implantation in one eye and serve as their own control in the fellow eye. Inclusion criteria: age ≥ 18 years, bilateral cataracts with high myopia eligible for surgery. Exclusion criteria: ocular comorbidities (e.g., glaucoma, retinal disease), history of major ocular trauma or surgery, and other causes of vision loss. Patients will be grouped based on axial length: Group A (AL ≤ 28 mm), Group B (28 mm < AL ≤ 30 mm), and Group C (AL > 30 mm).
Study Procedure:
Participants will be recruited after signing informed consent and passing pre-screening assessments. All subjects will receive detailed explanations regarding study purpose, procedures, risks, and postoperative care. Baseline examinations will include biometry, axial length, anterior segment measurements, and corneal topography. After surgery, patients will be followed up at 1 day, 1 week, 1 month, 3 months, and 6 months. Examinations include visual acuity, refraction, intraocular pressure, IOL position (decentration and tilt via anterior segment OCT), and visual quality analysis (iTrace). All data will be securely managed, and the final analysis will compare visual outcomes and IOL stability between the CTR and non-CTR eyes in highly myopic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a self-controlled study. Each participant receives cataract surgery in both eyes, with one eye randomly assigned to CTR implantation and the fellow eye without CTR. The two eyes serve as within-subject comparators.
| Arm | Type | Receives |
|---|---|---|
| CTR implantation | Experimental | Procedure: CTR implantationPhaco+IOL with CTR implantation |
| NCTR | No intervention | –Phaco+IOL without CTR implantation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Diagnosed with bilateral age-related cataracts and scheduled for phacoemulsification with IOL implantation in both eyes.
- High myopia in both eyes, defined as axial length (AL) ≥ 26.0 mm.
- No significant difference in axial length between the two eyes (e.g., interocular AL difference < 1.0 mm).
- Willingness and ability to undergo bilateral surgery within a short interval (e.g., within 1-2 weeks).
Key exclusion criteria (6 listed)
- History of ocular trauma, surgery, or intraocular inflammation in either eye.
- Presence of other ocular diseases that may affect visual outcomes, such as glaucoma, diabetic retinopathy, macular degeneration, or corneal opacity.
- Evidence of zonular weakness, pseudoexfoliation, or significant phacodonesis preoperatively.
- Severe dry eye or poor fixation that may interfere with postoperative imaging.
- Systemic diseases affecting visual function (e.g., uncontrolled diabetes, neurologic disorders).
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 |
|---|---|---|
| CTR implantationPhaco+IOL with CTR implantation | Procedure or surgery | CTR implantation |
Primary outcome
Tilt and Decentration
Time frame: Postoperative follow-up visits will be scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months
measured by using anterior segment OCT
3 secondary outcomes
Anterior Capsular Contraction
Time frame: 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively
visual acuity
Time frame: 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively
Visual Quality
Time frame: 1 day, 1 week, 1 month, 3 months, and 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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.
Baoxian Zhuo contact
Jin Yang study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTR implantation in people with High Myopia and Cataract, run by Jin Yang 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuanqiao Lin (+8615088920668, 1532483480@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tilt and Decentration (time frame: Postoperative follow-up visits will be scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months). 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 7 Jul 2025.