CataractNCT07126470
Impact of Capsular Tension Ring on Intraocular Lens Position in Retinitis Pigmentosa Cataract Patients
A study testing CTR implantation in people with Cataract and Retinitis Pigmentosa (RP), run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 3 sites in China.
Trial summary
This is a self-controlled randomized clinical trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) position in cataract patients with retinitis pigmentosa(RP). 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 years and older
- Conditions the study is for
- Cataract, Retinitis Pigmentosa (RP)
- 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
- 88 participants
- Where
- 3 sitesChina
- Study dates
- 25 Aug 2025to Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Clinical diagnosis of retinitis pigmentosa (RP).
- Bilateral cataract meeting the indications for IOL implantation.
- Willingness to participate in the study and provision of signed informed consent.
Who cannot join
- History of intraocular surgery.
- Severe zonular weakness (e.g., zonular dialysis >90°, lens subluxation/dislocation)
- Other ocular comorbidity: such as pseudoexfoliation syndrome, ocular trauma, corneal dystrophies, uveitis, etc.
- Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510623
Xuhua Tan, PhD, 8613926019722, doctxh@163.com
- Not yet recruiting
Shenzhen Eye Hospital
Shenzhen, Guangdong, 518040
Kun Zeng, 86-755-23959600, szsykyyxf@163.com
- Not yet recruiting
Wuhan Aier Eye Hospital
Wuhan, Hubei, 430061
Yong Wang, 027-68893999, 800013221@qq.com
About this study
Official title: Effect of Capsular Tension Ring Implantation on Postoperative IOL Position in Retinitis Pigmentosa Patients With Cataract: a Multi-center, Randomized, Self-controlled Study
This is a self-controlled randomized clinical trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) position in cataract patients with retinitis pigmentosa(RP). Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, IOL position, and postoperative complications will be compared between eyes.
Read the detailed description
Patients with retinitis pigmentosa (RP) have a higher risk of developing cataracts, often accompanied by abnormalities such as zonular laxity and vitreous liquefaction, which increases the risk of intraocular lens (IOL) tilt, decentration, and capsular contraction after surgery. The capsular tension ring (CTR) can support the zonules and maintain the stability of the capsular bag, but its effect in RP patients remains controversial.
In this self-controlled clinical trial, we are going to recruit 88 RP patients scheduled for bilateral cataract surgery. Both eyes receive a monofocal DCB00 IOL, while only on eye receives an additional CTR. Follow up visits take place 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. At the follow up visits, IOL decentration and tilt (determined by anterior segment SS-OCT Casia 2), visual acuity, and postoperative complications will be compared intraindividually at different timepoints.
- Conditions
- Cataract, Retinitis Pigmentosa (RP)
- Being tested
- CTR implantation
- Medical subject headings
- Cataract, Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTR implantationProcedure or surgery
Device: CTR (275001G, OPHTEC BV, Netherlands) All patients undergo uneventful phacoemulsification by a 2.2 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 (J\&J Tecnis DCB00) is implanted.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group: IOL Plus CTR implantation | Experimental | Patients will undergo phacoemulsification combined with IOL and CTR implantation Receives: Procedure: CTR implantation |
| Control Group: IOL implantation Only | No intervention | Patients will undergo phacoemulsification combined with IOL implantation. All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL (J\&J Tecnis DCB00) is implanted in the capsular bag. |
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 (4)
IOL dencentration
Measured by anterior segment OCT (CASIA2)
Measured: Baseline (before surgery), 1 week, 1 month, 6 months, 1 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 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 after surgery
Postoperative complications
Postoperative complications such as posterior capsular opacification, anterior capsule contraction, cystoid macular edema are examined by slit lamp photograph and other devices if necessary.
Measured: 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start25 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Model description
- This is an intraindividual comparative study. Each participant receives bilateral cataract surgery, with one eye randomly assigned to CTR implantation and the other eye without CTR.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuhua Tan, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126470
- Sponsor's protocol ID
- 2025KYPJ066
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Capsular Tension Ring Implantation on Postoperative IOL Position in Retinitis Pigmentosa Patients With Cataract: a Multi-center, Randomized, Self-controlled Study
- ClinicalTrials.gov ID
- NCT07126470
- Acronym / sponsor ID
- 2025KYPJ066
- Conditions
- Cataract, Retinitis Pigmentosa (RP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 17 Aug 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.
This is a self-controlled randomized clinical trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) position in cataract patients with retinitis pigmentosa(RP). Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, IOL position, and postoperative complications will be compared between eyes.
Detailed description
Patients with retinitis pigmentosa (RP) have a higher risk of developing cataracts, often accompanied by abnormalities such as zonular laxity and vitreous liquefaction, which increases the risk of intraocular lens (IOL) tilt, decentration, and capsular contraction after surgery. The capsular tension ring (CTR) can support the zonules and maintain the stability of the capsular bag, but its effect in RP patients remains controversial.
In this self-controlled clinical trial, we are going to recruit 88 RP patients scheduled for bilateral cataract surgery. Both eyes receive a monofocal DCB00 IOL, while only on eye receives an additional CTR. Follow up visits take place 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. At the follow up visits, IOL decentration and tilt (determined by anterior segment SS-OCT Casia 2), visual acuity, and postoperative complications will be compared intraindividually at different timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is an intraindividual comparative study. Each participant receives bilateral cataract surgery, with one eye randomly assigned to CTR implantation and the other eye without CTR.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group: IOL Plus CTR implantation | Experimental | Procedure: CTR implantationPatients will undergo phacoemulsification combined with IOL and CTR implantation |
| Control Group: IOL implantation Only | No intervention | –Patients will undergo phacoemulsification combined with IOL implantation. All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL (J\&J Tecnis DCB00) is implanted in the capsular bag. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Clinical diagnosis of retinitis pigmentosa (RP).
- Bilateral cataract meeting the indications for IOL implantation.
- Willingness to participate in the study and provision of signed informed consent.
Key exclusion criteria (4 listed)
- History of intraocular surgery.
- Severe zonular weakness (e.g., zonular dialysis >90°, lens subluxation/dislocation)
- Other ocular comorbidity: such as pseudoexfoliation syndrome, ocular trauma, corneal dystrophies, uveitis, etc.
- Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.
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 implantationDevice: CTR (275001G, OPHTEC BV, Netherlands) All patients undergo uneventful phacoemulsification by a 2.2 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 (J\&J Tecnis DCB00) is implanted. | Procedure or surgery | Treatment Group: IOL Plus CTR implantation |
Primary outcome
IOL dencentration
Time frame: 3 months after surgery
Measured by anterior segment OCT (CASIA2)
4 secondary outcomes
IOL dencentration
Time frame: Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery
IOL tilt
Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery
BCVA
Time frame: Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Postoperative complications
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year after surgery
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 Apr 2026.
- 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.
Xuhua Tan, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
3 sites 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 Cataract and Retinitis Pigmentosa (RP), run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 3 sites 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 4 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Yuke Pan, Master (8613060768121, 1693156383@qq.com), or a site near the patient. 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?
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 Apr 2026.