Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07126470

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

Led by Zhongshan Ophthalmic Center, Sun Yat-sen University · Updated on 2026-04-23

88

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study the effects of capsular tension ring (CTR) implantation on the position of intraocular lenses (IOL) in patients with cataracts who also have retinitis pigmentosa (RP). RP patients often face higher risks during cataract surgery due to issues like zonular weakness and vitreous changes, which can cause IOL tilt, decentration, and capsular contraction. This trial is designed as a randomized, self-controlled study where each patient serves as their own control, allowing direct comparison between eyes. Participants will undergo bilateral cataract surgery. One eye will receive a combined implantation of a monofocal IOL (J&J Tecnis DCB00) and a capsular tension ring (CTR), while the other eye will receive only the IOL. The CTR is implanted after removing the lens nucleus and cortex using standard phacoemulsification through a small corneal incision, aiming to support the capsular bag and zonules. Follow-up visits are scheduled at 1 week, 1 month, 3 months, 6 months, and 1 year after surgery to monitor outcomes. During follow-up visits, researchers will measure IOL decentration and tilt using anterior segment SS-OCT imaging (Casia 2), assess visual acuity, and record any postoperative complications. The primary outcome is IOL decentration measured at 3 months post-surgery. Secondary outcomes include additional measurements of IOL position, visual acuity, and complications at multiple time points. The total study duration for each participant is one year post-surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical diagnosis of retinitis pigmentosa (RP)
  • Bilateral cataract requiring intraocular lens implantation
  • Willingness to participate and provide signed informed consent
Not Eligible

You will not qualify if you...

  • History of intraocular surgery
  • Severe zonular weakness such as zonular dialysis greater than 90 degrees, lens subluxation or dislocation
  • Other ocular conditions including pseudoexfoliation syndrome, ocular trauma, corneal dystrophies, or uveitis
  • Severe systemic diseases like severe hypertension, diabetes, heart disease, Alzheimer's disease, or Parkinson's disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo bilateral cataract surgery. One eye receives an intraocular lens (IOL) plus a capsular tension ring (CTR), and the other eye receives only the IOL.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 1 year

Participants have follow-up visits to assess intraocular lens position, visual acuity, and postoperative complications.

5 visits at 1 week, 1 month, 3 months, 6 months, and 1 year post-surgery (in-person)

Trial Site Locations

Total: 3 locations

1

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China, 510623

Actively Recruiting

2

Shenzhen Eye Hospital

Shenzhen, Guangdong, China, 518040

Not Yet Recruiting

3

Wuhan Aier Eye Hospital

Wuhan, Hubei, China, 430061

Not Yet Recruiting

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Research Team

Y

Yuke Pan, Master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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