Cataract, Retinitis Pigmentosa (RP)
Conditions
Brief summary
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.
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.
Interventions
PROCEDURECTR 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.
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is an intraindividual comparative study. Each participant receives bilateral cataract surgery, with one eye randomly assigned to CTR implantation and the other eye without CTR.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOL dencentration | 3 months after surgery | Measured by anterior segment OCT (CASIA2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOL dencentration | Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery | Measured by anterior segment OCT (CASIA2) |
| IOL tilt | Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery | Measured by anterior segment OCT (CASIA2) |
| BCVA | Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery | BCVA is evaluated with ETDRS visual acuity chart. |
| Postoperative complications | 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. |
Countries
China
Contacts
CONTACTYuke Pan, Master
PRINCIPAL_INVESTIGATORXuhua Tan, PhD
Zhongshan Ophthalmic Center, Sun Yat-sen University
Outcome results
None listed