CataractNCT05161520

Impact of Capsular Tension Ring Implantation on Intraocular Lens Position

A study testing phacoemulsification combined with IOL and CTR implantation and phacoemulsification combined with IOL implantation in people with Cataract and High Myopia, run by Xuhua Tan at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This is a randomized controlled trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) tilt and decentration in cataract patients with high myopia. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Cataract, High Myopia
What is being tested?: phacoemulsification combined with IOL and CTR implantation and phacoemulsification combined with IOL implantation
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 186 participants
Where: 1 siteChina
Study dates: 16 Dec 2021to Dec 2026
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

> 18 years old;
axis length≥26mm;
Visually significant cataract;
The patient is willing and able to complete all necessary follow-ups and examinations.

Who cannot join

Intraoperative or postoperative complications: such as intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, endophthalmitis, etc.;
Other ocular comorbidity: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;
History of intraocular surgery;
Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;
Any condition that the study physician considers to be an impediment to the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Impact of Capsular Tension Ring Implantation on Intraocular Lens Tilt and Decentration in Cataract Patients With High Myopia: a Randomized Controlled Trial

This is a randomized controlled trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) tilt and decentration in cataract patients with high myopia.

Read the detailed description

Exact positioning and alignment of the IOL with the visual axis are the prerequisites of high-quality visual performance after cataract surgery. A certain degree of IOL tilt and decentration occur after uneventful cataract surgery, most of which are clinically tolerant. However, the relatively large capsular bag volume, zonular weakness, and vitreous liquefaction in cataract patients with high myopia may increase the IOL position instability, such as tilt, decentration and even dislocation, leading to the deterioration of visual function. Thus, how to improve the long-term stability of IOL position in high myopic cataract patients is an urgent issue to be addressed.

Previous studies have shown that CTR implantation during cataract surgery can increase the IOL stability in patients with normal axial length; however, its impact on IOL position of cataract patients with high myopia remains unclear.

In this randomized clinical trial, patients who meet the inclusion criteria will be divided into three layers according to the axial length:

(1)26mm≤AL<28mm (2)28mm≤AL<30mm (3)AL≥30mm

We are going to recruit 186 patients in total, with 62 patients in each layer. Patients on each layer will be randomly divided into experimental group (CTR implantation) and control group (only IOL implantation). If both eyes of a patient meet the inclusion criteria, only the first operated eye is included in the statistics analysis.

All included patients will be followed up at 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. Visual acuity, IOL tilt, IOL decentration, posterior capsule attachment with IOL, anterior capsule contraction, posterior capsular opacification, and visual quality will be measured and compared between the experimental group and the control group at different timepoints.

Conditions: Cataract, High Myopia
Being tested: phacoemulsification combined with IOL and CTR implantation, phacoemulsification combined with IOL implantation
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

phacoemulsification combined with IOL and CTR implantationProcedure or surgery
Device: CTR (276001G； OPHTEC BV, Netherlands) Device: IOL (920H; Rayner Intracular Lenses Limited，Hove，East Sussex，UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, a capsular tension ring is implanted in the capsular bag and then IOL is implanted.
phacoemulsification combined with IOL implantationProcedure or surgery
Device: IOL (920H; Rayner Intracular Lenses Limited，Hove，East Sussex，UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag.

Study groups in NCT05161520
Study group	Role	What they receive
IOL plus CTR Patients will undergo phacoemulsification combined with IOL and CTR implantation.	Active comparator	Not described Receives: Procedure: phacoemulsification combined with IOL and CTR implantation
single IOL Patients will undergo phacoemulsification combined with IOL implantation.	Placebo comparator	Not described Receives: Procedure: phacoemulsification combined with IOL implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

IOL dencentration
Measured by anterior segment OCT (CASIA2)
Measured: 3 months after surgery

Secondary outcomes (10)

IOL dencentration
Measured by anterior segment OCT (CASIA2)
Measured: Baseline (before surgery), 1 week, 1 month, 6 months, 1 year, 3 year after surgery
IOL tilt
Measured by anterior segment OCT (CASIA2)
Measured: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Anterior capsule contraction
Compare the area of anterior capsule opening recorded by slit lamp photograph and analyzed by Image J software.
Measured: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Posterior capsule attachment with IOL
Measured by anterior segment OCT (CASIA2) and analyzed by Image J software.
Measured: 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Posterior capsular opacification
Recorded by slit lamp photograph and analyzed by EPCO2000 analysis software.
Measured: 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
BCVA
BCVA is evaluated with ETDRS visual acuity chart.
Measured: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Optical quality
Measured by OPD-SCAN III.
Measured: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Visual function
Measured by visual function assessment questionnaires.
Measured: 3 months, 6 months, 1 year, 3 year after surgery
Incidence of postoperative complications
IOL dislocation, retinal detachment, etc.
Measured: 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Time to Nd:YAG posterior capsulotomy
Time from cataract surgery to Nd:YAG laser posterior capsulotomy. Participants without capsulotomy will be censored at their last follow-up visit. Cumulative probability of capsulotomy over time will be estimated using Kaplan-Meier survival analysis.
Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 2021Dec 2026

First posted17 Dec 2021
Study start16 Dec 2021
Primary completion22 Dec 2023
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 186 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05161520
Sponsor's protocol ID: 2021KYPJ128
Status last verified: Sep 2026
First submitted: 2 Dec 2021
Last updated: 23 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lin H, Zhang J, Jin A, Zhang Y, Zhang Y, Jin L, Xu Y, Xie X, Qiu X, Dai B, Tan X, Luo L, Liu Y. Capsular Tension Ring Implantation for Intraocular Lens Power Calculation in Highly Myopic Eyes: Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2025 May 1;143(5):373-381. doi: 10.1001/jamaophthalmol.2025.0110.
PubMed 40111331
Lin H, Zhang J, Zhang Y, Jin A, Zhang Y, Jin L, Xu Y, Xie X, Tan X, Luo L, Liu Y. Capsular Tension Ring Implantation for Intraocular Lens Decentration and Tilt in Highly Myopic Eyes: A Randomized Clinical Trial. JAMA Ophthalmol. 2024 Aug 1;142(8):708-715. doi: 10.1001/jamaophthalmol.2024.2215.
PubMed 38935400

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Capsular Tension Ring Implantation on Intraocular Lens Tilt and Decentration in Cataract Patients With High Myopia: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05161520
Acronym / sponsor ID: 2021KYPJ128
Conditions: Cataract, High Myopia
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 186 participants (estimated)
Lead sponsor: Xuhua TanUniversity, hospital or other
Study start: 16 Dec 2021 (actual)
Primary completion: 22 Dec 2023 (actual)
Study completion: Dec 2026 (estimated)
First posted: 17 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.

This is a randomized controlled trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) tilt and decentration in cataract patients with high myopia.

Detailed description

In this randomized clinical trial, patients who meet the inclusion criteria will be divided into three layers according to the axial length:

(1)26mm≤AL<28mm (2)28mm≤AL<30mm (3)AL≥30mm

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IOL plus CTR Patients will undergo phacoemulsification combined with IOL and CTR implantation.	Active comparator	Procedure: phacoemulsification combined with IOL and CTR implantation
single IOL Patients will undergo phacoemulsification combined with IOL implantation.	Placebo comparator	Procedure: phacoemulsification combined with IOL implantation

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

> 18 years old;
axis length≥26mm;
Visually significant cataract;
The patient is willing and able to complete all necessary follow-ups and examinations.

Key exclusion criteria (5 listed)

Intraoperative or postoperative complications: such as intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, endophthalmitis, etc.;
Other ocular comorbidity: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;
History of intraocular surgery;
Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;
Any condition that the study physician considers to be an impediment to the clinical trial.

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
phacoemulsification combined with IOL and CTR implantationDevice: CTR (276001G； OPHTEC BV, Netherlands) Device: IOL (920H; Rayner Intracular Lenses Limited，Hove，East Sussex，UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, a capsular tension ring is implanted in the capsular bag and then IOL is implanted.	Procedure or surgery	IOL plus CTR Patients will undergo phacoemulsification combined with IOL and CTR implantation.
phacoemulsification combined with IOL implantationDevice: IOL (920H; Rayner Intracular Lenses Limited，Hove，East Sussex，UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag.	Procedure or surgery	single IOL Patients will undergo phacoemulsification combined with IOL implantation.

Primary outcome

IOL dencentration
Time frame: 3 months after surgery
Measured by anterior segment OCT (CASIA2)

10 secondary outcomes

IOL dencentration
Time frame: Baseline (before surgery), 1 week, 1 month, 6 months, 1 year, 3 year after surgery
IOL tilt
Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Anterior capsule contraction
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Posterior capsule attachment with IOL
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Posterior capsular opacification
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
BCVA
Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Optical quality
Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Visual function
Time frame: 3 months, 6 months, 1 year, 3 year after surgery
Incidence of postoperative complications
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, 3 year after surgery
Time to Nd:YAG posterior capsulotomy
Time frame: Up to 3 years

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 23 Sep 2026.
Derived from this study: PubMed 40111331Lin H, Zhang J, Jin A, Zhang Y, Zhang Y, Jin L, Xu Y, Xie X, Qiu X, Dai B, Tan X, Luo L, Liu Y. Capsular Tension Ring Implantation for Intraocular Lens Power Calculation in Highly Myopic Eyes: Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2025 May 1;143(5):373-381. doi: 10.1001/jamaophthalmol.2025.0110.
Derived from this study: PubMed 38935400Lin H, Zhang J, Zhang Y, Jin A, Zhang Y, Jin L, Xu Y, Xie X, Tan X, Luo L, Liu Y. Capsular Tension Ring Implantation for Intraocular Lens Decentration and Tilt in Highly Myopic Eyes: A Randomized Clinical Trial. JAMA Ophthalmol. 2024 Aug 1;142(8):708-715. doi: 10.1001/jamaophthalmol.2024.2215.

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Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. 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. 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?

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?

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?

IOL dencentration (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05161520, which also lists 2 linked publications.

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 23 Sep 2026.