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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

88

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • 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)

August 25, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

August 10, 2025

First Submitted That Met QC Criteria

August 10, 2025

First Posted (Actual)

August 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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