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

NCT07126470 | Recruiting

• 1 other identifier: 2025KYPJ066
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

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.

Conditions

Cataract; Retinitis Pigmentosa (RP)

Outcome Measures

Primary Outcomes (1)

• IOL dencentration

  Measured by anterior segment OCT (CASIA2)

  3 months after surgery

Secondary Outcomes (4)

• IOL dencentration

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

• IOL tilt

  Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery

• BCVA

  Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery

• Postoperative complications

  1 week, 1 month, 3 months, 6 months, 1 year after surgery

Study Arms (2)

Treatment Group: IOL Plus CTR implantation

EXPERIMENTAL

Patients will undergo phacoemulsification combined with IOL and CTR implantation

Procedure: CTR implantation

Control Group: IOL implantation Only

NO INTERVENTION

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.

Interventions

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.

Treatment Group: IOL Plus CTR implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (3)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510623, China

RECRUITING

Shenzhen Eye Hospital

Shenzhen, Guangdong, 518040, China

NOT YET RECRUITING

Wuhan Aier Eye Hospital

Wuhan, Hubei, 430061, China

NOT YET RECRUITING

MeSH Terms

Conditions

Cataract; Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Eye Diseases, Hereditary; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xuhua Tan, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuke Pan, Master

CONTACT

8613060768121; 1693156383@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)