Impact of Capsular Tension Ring on Intraocular Lens Position in Retinitis Pigmentosa Cataract Patients

April 20, 2026 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
      • Shenzhen, Guangdong, China, 518040
        • Not yet recruiting
        • Shenzhen Eye Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430061
        • Not yet recruiting
        • Wuhan Aier Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group: IOL Plus CTR implantation
Patients will undergo phacoemulsification combined with IOL and CTR implantation
Procedure: CTR implantation
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.
No Intervention: Control Group: IOL implantation Only
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IOL dencentration
Time Frame: 3 months after surgery
Measured by anterior segment OCT (CASIA2)
3 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IOL dencentration
Time Frame: Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery
Measured by anterior segment OCT (CASIA2)
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
Measured by anterior segment OCT (CASIA2)
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
BCVA is evaluated with ETDRS visual acuity chart.
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
Postoperative complications such as posterior capsular opacification, anterior capsule contraction, cystoid macular edema are examined by slit lamp photograph and other devices if necessary.
1 week, 1 month, 3 months, 6 months, 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xuhua Tan, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025KYPJ066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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