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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CTR implantation

    Procedure/Surgery

    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 groups

88 Participants
are divided into 2 treatment groups
Group A: Treatment Group: IOL Plus CTR implantationExperimental treatment 1 intervention
Group B: Control Group: IOL implantation OnlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

IOL dencentration

Measured by anterior segment OCT (CASIA2)

Time frame
3 months after surgery

Secondary outcomes

1

IOL dencentration

Measured by anterior segment OCT (CASIA2)

Time frame
Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery
2

IOL tilt

Measured by anterior segment OCT (CASIA2)

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

BCVA

BCVA is evaluated with ETDRS visual acuity chart.

Time frame
Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery
4

Postoperative complications

Postoperative complications such as posterior capsular opacification, anterior capsule contraction, cystoid macular edema are examined by slit lamp photograph and other devices if necessary.

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

Other outcomes

Sponsors and contacts

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