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.
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
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.
- Conditions
- Cataract, Astigmatism, Intraocular Lens Rotation
- 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 group | Role | What they receive |
|---|---|---|
| CTR group | This group include the patients with the usage of CTR Receives: Procedure: intraoperative implantation of Capsular Tension Ring | |
| control group | This 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.
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.
- First posted26 Aug 2024
- Study start1 Jan 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yilin, Shanghai 10th People's Hospital
- Investigators
- Yili Sun, Principal investigator, Shanghai 10th People's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06571773
- Acronym / sponsor ID
- SHISY-LYZX-217
- Conditions
- Cataract, Astigmatism, Intraocular Lens Rotation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTR group | – | Procedure: intraoperative implantation of Capsular Tension RingThis group include the patients with the usage of CTR |
| control group | – | Procedure: none intraoperative implantation of CTRThis group include the patients without the usage of CTR |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative implantation of Capsular Tension RingThe 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 | Procedure or surgery | CTR group |
| none intraoperative implantation of CTRthe surgeon did a surgery without the intraoperative implantation of CTR | Procedure or surgery | control group |
Primary outcome
Postoperative IOL rotation degree
Time frame: 3 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yili Sun principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
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.