Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07126470

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CTR implantation

Procedure

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.

Primary outcomes

  1. IOL dencentration

    Time frame: 3 months after surgery

    Measured by anterior segment OCT (CASIA2)

Secondary outcomes

  1. IOL dencentration

    Time frame: Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery

    Measured by anterior segment OCT (CASIA2)

  2. 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)

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuke Pan, Master

CONTACT

[email protected]

8613060768121

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

Effect of Capsular Tension Ring Implantation on Postoperative IOL Position in Retinitis Pigmentosa Patients With Cataract: a Multi-center, Randomized, Self-controlled Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.