Intraocular Lens RotationNCT05530473
Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts
A study testing capsular tension ring in people with Intraocular Lens Rotation and Capsular Tension Ring, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intraocular Lens Rotation, Capsular Tension Ring
- What is being tested?
- capsular tension ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Mar 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -cataract
Who cannot join
- preexisting corneal pathology
- small pupil
- glaucoma
- zonular dehiscence
- a history of ocular trauma or surgery
- uveitis
- intraoperative complications
Trial locations and contacts
1 site in 1 country.
China1 site
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery.
- Conditions
- Intraocular Lens Rotation, Capsular Tension Ring
- Being tested
- capsular tension ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsular tension ringDevice
Also called capsular tension ring (ACPi-11; Bausch&Lomb)
To insert a capsular tension ring during the cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| CTR Group | Experimental | Eyes had a capsular tension ring (CTR) implanted into the capsular bag during the cataract surgery. Receives: Device: capsular tension ring |
| NCTR Group | No intervention | Eyes underwent cataract surgery without implanting a CTR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL rotation degree at one hour
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: one hour
IOL rotation degree at 1 day
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: one day
IOL rotation degree at 3 days
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: three days
IOL rotation degree at 1 week
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: one week
IOL rotation degree at 2 weeks
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: two weeks
IOL rotation degree at 1 month
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: one month
IOL rotation degree at 3 months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: three months
IOL rotation degree at 6 months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: three months
IOL rotation degree at 12 months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: three months
Residual astigmatism (RAS) at two weeks
RAS after surgery, which was measured as manifest refraction at two weeks
Measured: two weeks
Residual astigmatism (RAS) at one month
RAS after surgery, which was measured as manifest refraction at one month
Measured: one month
Secondary outcomes (15)
visual acuity (VA) at 1 day
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
Measured: two weeks
visual acuity (VA) at 3 days
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
Measured: two weeks
visual acuity (VA) at 1 weeks
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
Measured: two weeks
visual acuity (VA) at 2 weeks
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
Measured: two weeks
visual acuity (VA) at 1 month
Uncorrected distance visual acuity (UDVA) of participants after surgery at one month
Measured: one month
visual acuity (VA) at 3 months
Uncorrected distance visual acuity (UDVA) of participants after surgery at three months
Measured: three months
visual acuity (VA) at 6 months
Uncorrected distance visual acuity (UDVA) of participants after surgery at six months
Measured: six months
visual acuity (VA) at 12 months
Uncorrected distance visual acuity (UDVA) of participants after surgery at twelve months
Measured: twelve months
IOL tilt at 1 day
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: one day
IOL tilt at 3 days
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: three days
IOL tilt at 1 week
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: one week
IOL tilt at 2 weeks
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: two weeks
IOL tilt at 1 month
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: one month
IOL tilt at 3 months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: three months
IOL tilt at 6 months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jan 2020
- Primary completion1 Dec 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraocular Lens RotationStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Jin Yang, Eye & ENT Hospital of Fudan University
- Investigators
- Jin Yang, PhD, Principal investigator, Eye & ENT Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530473
- Sponsor's protocol ID
- IOL&CTR
- Status last verified
- Apr 2023
- First submitted
- 30 Aug 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lin X, Ma D, Han X, Hua Z, Shen W, Qiu X, Cai L, Yang J. Rotational stability of plate-haptic toric intraocular lenses implantation with a capsular tension ring: prospective randomized paired-eye study. J Cataract Refract Surg. 2025 Jan 1;51(1):31-39. doi: 10.1097/j.jcrs.0000000000001554.
PubMed 39353092
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts
- ClinicalTrials.gov ID
- NCT05530473
- Acronym / sponsor ID
- IOL&CTR
- Conditions
- Intraocular Lens Rotation, Capsular Tension Ring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 7 Sep 2022 (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.
This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTR Group | Experimental | Device: capsular tension ringEyes had a capsular tension ring (CTR) implanted into the capsular bag during the cataract surgery. |
| NCTR Group | No intervention | –Eyes underwent cataract surgery without implanting a CTR. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -cataract
Key exclusion criteria (7 listed)
- preexisting corneal pathology
- small pupil
- glaucoma
- zonular dehiscence
- a history of ocular trauma or surgery
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 |
|---|---|---|
| capsular tension ringAlso: capsular tension ring (ACPi-11; Bausch&Lomb)To insert a capsular tension ring during the cataract surgery | Device | CTR Group |
Primary outcome
IOL rotation degree at one hour
Time frame: one hour
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 1 day
Time frame: one day
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 3 days
Time frame: three days
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 1 week
Time frame: one week
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 2 weeks
Time frame: two weeks
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 1 month
Time frame: one month
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 3 months
Time frame: three months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 6 months
Time frame: three months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 12 months
Time frame: three months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Residual astigmatism (RAS) at two weeks
Time frame: two weeks
RAS after surgery, which was measured as manifest refraction at two weeks
Residual astigmatism (RAS) at one month
Time frame: one month
RAS after surgery, which was measured as manifest refraction at one month
15 secondary outcomes
visual acuity (VA) at 1 day
Time frame: two weeks
visual acuity (VA) at 3 days
Time frame: two weeks
visual acuity (VA) at 1 weeks
Time frame: two weeks
visual acuity (VA) at 2 weeks
Time frame: two weeks
visual acuity (VA) at 1 month
Time frame: one month
visual acuity (VA) at 3 months
Time frame: three months
visual acuity (VA) at 6 months
Time frame: six months
visual acuity (VA) at 12 months
Time frame: twelve months
IOL tilt at 1 day
Time frame: one day
IOL tilt at 3 days
Time frame: three days
IOL tilt at 1 week
Time frame: one week
IOL tilt at 2 weeks
Time frame: two weeks
IOL tilt at 1 month
Time frame: one month
IOL tilt at 3 months
Time frame: three months
IOL tilt at 6 months
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 39353092Lin X, Ma D, Han X, Hua Z, Shen W, Qiu X, Cai L, Yang J. Rotational stability of plate-haptic toric intraocular lenses implantation with a capsular tension ring: prospective randomized paired-eye study. J Cataract Refract Surg. 2025 Jan 1;51(1):31-39. doi: 10.1097/j.jcrs.0000000000001554.
- Individual participant dataSharing planned: Undecided
Related trials for Intraocular Lens Rotation
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
RecruitingObservational study
Intraocular Lens Implant Registry Study
Intraocular Lens Complication, Intraocular Lens Rotation
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.
Jin Yang, PhD principal investigator
Eye & ENT Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capsular tension ring in people with Intraocular Lens Rotation and Capsular Tension Ring, run by Eye & ENT Hospital of Fudan University 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 28 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IOL rotation degree at one hour (time frame: one hour). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530473, which also lists 1 linked publication.
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 Apr 2023.