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NCT Number: NCT05161520

Impact of Capsular Tension Ring Implantation on Intraocular Lens Position

This is a randomized controlled trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) tilt and decentration in cataract patients with high myopia.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

Exact positioning and alignment of the IOL with the visual axis are the prerequisites of high-quality visual performance after cataract surgery. A certain degree of IOL tilt and decentration occur after uneventful cataract surgery, most of which are clinically tolerant. However, the relatively large capsular bag volume, zonular weakness, and vitreous liquefaction in cataract patients with high myopia may increase the IOL position instability, such as tilt, decentration and even dislocation, leading to the deterioration of visual function. Thus, how to improve the long-term stability of IOL position in high myopic cataract patients is an urgent issue to be addressed.

Previous studies have shown that CTR implantation during cataract surgery can increase the IOL stability in patients with normal axial length; however, its impact on IOL position of cataract patients with high myopia remains unclear.

In this randomized clinical trial, patients who meet the inclusion criteria will be divided into three layers according to the axial length:

(1)26mm≤AL<28mm (2)28mm≤AL<30mm (3)AL≥30mm

We are going to recruit 186 patients in total, with 62 patients in each layer. Patients on each layer will be randomly divided into experimental group (CTR implantation) and control group (only IOL implantation). If both eyes of a patient meet the inclusion criteria, only the first operated eye is included in the statistics analysis.

All included patients will be followed up at 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. Visual acuity, IOL tilt, IOL decentration, posterior capsule attachment with IOL, anterior capsule contraction, posterior capsular opacification, and visual quality will be measured and compared between the experimental group and the control group at different timepoints.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years old;
  • axis length≥26mm;
  • Visually significant cataract;
  • The patient is willing and able to complete all necessary follow-ups and examinations.

Exclusion criteria

  • Intraoperative or postoperative complications: such as intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, endophthalmitis, etc.;
  • Other ocular comorbidity: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;
  • History of intraocular surgery;
  • Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;
  • Any condition that the study physician considers to be an impediment to the clinical trial.

Treatment and study plan

phacoemulsification combined with IOL and CTR implantation

Procedure

Device: CTR (276001G; OPHTEC BV, Netherlands) Device: IOL (920H; Rayner Intracular Lenses Limited,Hove,East Sussex,UK) All patients undergo uneventful phacoemulsification by a 3.0 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 is implanted.

phacoemulsification combined with IOL implantation

Procedure

Device: IOL (920H; Rayner Intracular Lenses Limited,Hove,East Sussex,UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag.

Primary outcomes

  1. IOL dencentration

    Time frame: 3 months after surgery

    Measured by anterior segment OCT (CASIA2)

Secondary outcomes

  1. IOL dencentration

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

    Measured by anterior segment OCT (CASIA2)

  2. IOL tilt

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

    Measured by anterior segment OCT (CASIA2)

  3. Anterior capsule contraction

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

    Compare the area of anterior capsule opening recorded by slit lamp photograph and analyzed by Image J software.

  4. Posterior capsule attachment with IOL

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

    Measured by anterior segment OCT (CASIA2) and analyzed by Image J software.

  5. Posterior capsular opacification

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

    Recorded by slit lamp photograph and analyzed by EPCO2000 analysis software.

  6. BCVA

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

    BCVA is evaluated with ETDRS visual acuity chart.

  7. Optical quality

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

    Measured by OPD-SCAN III.

  8. Visual function

    Time frame: 3 months, 6 months, 1 year, 3 year after surgery

    Measured by visual function assessment questionnaires.

  9. Incidence of postoperative complications

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

    IOL dislocation, retinal detachment, etc.

  10. Time to Nd:YAG posterior capsulotomy

    Time frame: Up to 3 years

    Time from cataract surgery to Nd:YAG laser posterior capsulotomy. Participants without capsulotomy will be censored at their last follow-up visit. Cumulative probability of capsulotomy over time will be estimated using Kaplan-Meier survival analysis.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Xuhua Tan

Other

Registry information

Official study title

Impact of Capsular Tension Ring Implantation on Intraocular Lens Tilt and Decentration in Cataract Patients With High Myopia: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Dec 17, 2021
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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