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CataractNCT06571773

Evaluation of Toric Intraocular Lens(IOL) Combined With Capsular Tension Ring(CTR) in Patients With Cataract Combined With High Myopia

An observational study of Cataract and Astigmatism, run by Shanghai 10th People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to evaluate the postoperative visual quality and IOL stability in patients with cataracts and high myopia who have undergone surgery using astigmatism-correcting IOLs in conjunction with tension rings.It is a non-randomised retroprospective cohort study. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Cataract, Astigmatism, Intraocular Lens Rotation
What is being tested?
intraoperative implantation of Capsular Tension Ring and none intraoperative implantation of CTR
Type of treatment
Surgery or procedure
How many people
72 participants
Where
1 siteChina
Study dates
1 Jan 2024to 31 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Cataract ultrasonic emulsification aspiration with one-stage implantation of astigmatic IOL at the Shanghai Tenth People's Hospital from October 2020 to September 2023

Who may be able to join

  • Cataract ultrasonic emulsification aspiration with one-stage implantation of astigmatic IOL at the Shanghai Tenth People's Hospital from October 2020 to September 2023;
  • Ocular axial length ≥26.00mm;
  • Completion of outpatient follow up for more than 3 months.

Who cannot join

  • irregular corneal astigmatism, iris abnormalities, and pupil distortion;
  • history of previous corneal or intraocular surgery;
  • previous ocular diseases such as uveitis, retinopathy, macular degeneration, glaucoma, and keratoconus;
  • postoperative posterior capsule rupture, and suspensory ligament dissociation of greater than 1 quadrant;
  • corneal endothelial cell counts of less than 2000 cells/mm2.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shanghai 10th People's Hospital

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: Evaluation of Astigmatism-correcting IOL Combined With Tension Ring on Postoperative Visual Quality and Rotational Stability of IOLs in Patients With Cataract Combined With High Myopia

The objective of this study is to evaluate the postoperative visual quality and IOL stability in patients with cataracts and high myopia who have undergone surgery using astigmatism-correcting IOLs in conjunction with tension rings.It is a non-randomised retroprospective cohort study. Patients with high axial myopia (AL ≥ 26 mm) who underwent cataract phacoemulsification combined with toric IOL(Acrysof SN6ATY IQ toric IOL, Alcon, Alcon Laboratories, Fort Worth, Texas, USA) implantation from October 2020 to September 2023 at the Shanghai Tenth People's Hospital are selected. According to the usage of CTR, all patients will be divided into CTR group and control group, with a minimum follow-up of 3 months.Each patient underwent a comprehensive preoperative examination and ophthalmological examinations at the outpatient clinic 1 day, 1 week, 1 month, and 3 months postoperatively.Statistical analysis will be conducted using SPSS 26.0 statistical software.

Read the detailed description

Preoperative examination:Each patient underwent a comprehensive preoperative examination, which included evaluation of uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), corneal endothelial cells (CECs), axial length, corneal curvature, and corneal topography using subjective optometry, slit-lamp microscopy, funduscopic examination, intraocular pressure measurements, B-scan ultrasound of the eye, and corneal topography(Pentacam HR, OCULUS Optikgerate, Wetzlar, Germany), as well as other relevant parameters. Visual acuity was measured using a standard logarithmic visual acuity chart. Biometry of the operative eye was performed by a specialized technician using an IOL Master (IOLMaster 700, Carl Zeiss Meditec, Jena, Germany), and the Barret's formulaⅡ was applied to calculate the equivalent spherical equivalent (SE) of the toric IOL. The information was inputted into an online calculator (www.acrysoftoriccalculator.com) provided by Alcon to determine the necessary IOL refraction and axial position.

Surgery:The patients received tobramycin dexamethasone eye drops four times one day before surgery. Prior to surgery, the IOL axial position, the diameter size of continuous curvilinear capsulorhexis (CCC), and the incision position were measured and marked using the Image Guided System(VERION Reference Unit, Alcon GPS-WaveLight GmbH, Rheinstrasse, Germany). The pupil was dilated with compound tropicamide drops to a diameter of at least 8mm. The surgery was performed by an experienced surgeon following a standardized procedure. The surgical procedure was as follows: Proparacaine hydrochloride eye drops (ALCAINE, S.A.Alcon-Couvreur N.V., Belgium) were used to provide surface anaesthesia. The conjunctival sac was rinsed with 1% povidone-iodine. Afterwards, a 2.2-mm corneal incision and a 15° stab knife auxiliary incision were made under the guidance of digital navigation system. Inserting the viscoelastic into the anterior chamber and applying a continuous circular capsulorhexis method, a complete hydro dissection was performed. The lens nucleus was removed using ultrasonic emulsification, follow by aspirating the excess cortex and polishing the capsule. After propping up the capsular bag with viscoelastic, the intraocular lens (IOL) was implanted through the main incision (the CTR would be implanted before the IOL implantation). After suctioning off the viscoelastic, the IOL was adjusted to the predetermined axis under navigation guidance. Finally, the incision was hydrated. Tobramycin dexamethasone eye drops were used for 2 weeks postoperatively in all cases.

Postoperative management:All patients underwent ophthalmological examinations at the outpatient clinic 1 day, 1 week, 1 month, and 3 months postoperatively. The examinations included uncorrected distance visual acuity, intraocular pressure examination, subjective optometry, slit lamp microscopy, and SS-OCT (CASIA2, Tomey Corporation, Nagoya, Japan). The surgeon, using the same slit lamp microscope and a narrow band of light, measured the IOL axial position after the patients' pupils were fully dilated with compound tropicamide eye drops. The rotation degree was calculated as the absolute difference between the axial positions of the check and target.

Being tested
intraoperative implantation of Capsular Tension Ring, none intraoperative implantation of CTR
Medical subject headings
Cataract, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intraoperative implantation of Capsular Tension RingProcedure or surgery

    The Capsular Tension Ring(ACPi-11; Bausch + Lomb, Rochester, New York, USA) is a device made of PMMA with blunt-tipped eyelets at its ends. It can be inserted at any point during cataract surgery, following the creation of a strong anterior capsulotomy via capsulorhexis

  • none intraoperative implantation of CTRProcedure or surgery

    the surgeon did a surgery without the intraoperative implantation of CTR

Study groups in NCT06571773
Study groupRoleWhat they receive
CTR groupThis group include the patients with the usage of CTR
Receives: Procedure: intraoperative implantation of Capsular Tension Ring
control groupThis group include the patients without the usage of CTR
Receives: Procedure: none intraoperative implantation of CTR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative IOL rotation degree

    The surgeon, using the same slit lamp microscope and a narrow band of light, measured the IOL axial position after the patients' pupils were fully dilated with compound tropicamide eye drops

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start1 Jan 2024
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571773
Sponsor's protocol ID
SHISY-LYZX-217
Status last verified
Aug 2024
First submitted
23 Aug 2024
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and Astigmatism, run by Shanghai 10th People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative IOL rotation degree (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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