Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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