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

NCT ID: NCT07126470

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2027-08-31

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.

Conditions

Cataract; Retinitis Pigmentosa (RP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Group: IOL Plus CTR implantation

Patients will undergo phacoemulsification combined with IOL and CTR implantation

Group Type: EXPERIMENTAL

CTR implantation

Intervention Type: 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.

Control Group: IOL implantation Only

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CTR 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xuhua Tan, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuke Pan, Master

Role: CONTACT

1693156383@qq.com

8613060768121

Facility Contacts

Xuhua Tan, PhD

Role: primary

doctxh@163.com

8613926019722

Other Identifiers

2025KYPJ066

Identifier Type: -

Identifier Source: org_study_id