Toric Intraocular Lens StabilityNCT05797298
Toric Intraocular Lens (IOL) Implantation for Management of Cataracts
An observational study of Toric Intraocular Lens Stability and Visual Quality, run by Eye & ENT Hospital of Fudan University at 2 sites in China.
Trial summary
This study included cataract patients who underwent toric intraocular lens (IOL) implantation, which aimed to evaluate the stability and clinical visual quality of toric IOLs. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Toric Intraocular Lens Stability, Visual Quality
- How many people
- 3,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2019to 31 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Cataract patients who underwent uneventful lens phacoemulsification and toric IOL implantation.
Who may be able to join
- Cataract
Who cannot join
- • small pupil
- zonular dehiscence
- preexisting corneal pathology
- glaucoma
- uveitis
- a history of ocular trauma or surgery
- severe intraoperative and postoperative complications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, China, 200031
Jin Yang, PhD, 13671632525, jin_er76@hotmail.com
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Jin Yang, PhD, 13671632525, jin_er76@hotmail.com
Lei Cai, MD
About this study
Official title: Plate-haptic Toric Intraocular Lens (IOL) Implantation for Management of Cataracts
This study included cataract patients who underwent toric intraocular lens (IOL) implantation, which aimed to evaluate the stability and clinical visual quality of toric IOLs.
Read the detailed description
This study included cataract patients who underwent the implantation of toric intraocular lens (IOL) with haptic design, which aimed to evaluate the stability and clinical visual quality of toric IOLs.
- Conditions
- Toric Intraocular Lens Stability, Visual Quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cataract patients implanted with toric IOLs | Cataract patients who received the implantation of different toric IOLs with different haptic designs |
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 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 one day
After the pupil was dilated, the IOL axis was recorded 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 three days
After the pupil was dilated, the IOL axis was recorded 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 one week
After the pupil was dilated, the IOL axis was recorded 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 two weeks
After the pupil was dilated, the IOL axis was recorded 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 one month
After the pupil was dilated, the IOL axis was recorded 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 three months
After the pupil was dilated, the IOL axis was recorded 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 six months
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: six months
IOL rotation degree at one year
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: one year
IOL rotation degree at three years
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Measured: three years
IOL tilt at one week
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: one week
IOL tilt at two weeks
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: two weeks
IOL tilt at one month
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: one month
IOL tilt at three months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: three months
IOL tilt at six months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: six months
IOL tilt at one year
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: one year
IOL tilt at three years
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: three years
IOL decentration at one week
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
Measured: one week
IOL decentration at two weeks
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
Measured: two weeks
IOL decentration at one month
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
Measured: one month
IOL decentration at three months
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
Measured: three months
IOL decentration at six months
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
Measured: six months
IOL decentration at one year
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
Measured: one year
IOL decentration at three years
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
Measured: three years
Secondary outcomes (7)
visual quality at one week
visual acuity was evaluated by OPD-Scan III aberrometer.
Measured: one week
visual quality at two weeks
visual acuity was evaluated by OPD-Scan III aberrometer.
Measured: two weeks
visual quality at one month
visual acuity was evaluated by OPD-Scan III aberrometer.
Measured: one month
visual quality at three months
visual acuity was evaluated by OPD-Scan III aberrometer.
Measured: three months
visual quality at six months
visual acuity was evaluated by OPD-Scan III aberrometer.
Measured: six months
visual quality at one year
visual acuity was evaluated by OPD-Scan III aberrometer.
Measured: one year
visual quality at three years
visual acuity was evaluated by OPD-Scan III aberrometer.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Jun 2019
- Primary completion31 Mar 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toric Intraocular Lens StabilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yang, Eye & ENT Hospital of Fudan University
- Investigators
- Jin Yang, PhD, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797298
- Sponsor's protocol ID
- Toric IOL
- Status last verified
- Jun 2025
- First submitted
- 23 Nov 2022
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plate-haptic Toric Intraocular Lens (IOL) Implantation for Management of Cataracts
- ClinicalTrials.gov ID
- NCT05797298
- Acronym / sponsor ID
- Toric IOL
- Conditions
- Toric Intraocular Lens Stability, Visual Quality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 4 Apr 2023 (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 toric intraocular lens (IOL) implantation, which aimed to evaluate the stability and clinical visual quality of toric IOLs.
Detailed description
This study included cataract patients who underwent the implantation of toric intraocular lens (IOL) with haptic design, which aimed to evaluate the stability and clinical visual quality of toric IOLs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cataract patients implanted with toric IOLs | – | –Cataract patients who received the implantation of different toric IOLs with different haptic designs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cataract patients who underwent uneventful lens phacoemulsification and toric IOL implantation.
Key inclusion criteria (1 listed)
- Cataract
Key exclusion criteria (7 listed)
- • small pupil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IOL rotation degree at one hour
Time frame: one hour
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at one day
Time frame: one day
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at three days
Time frame: three days
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at one week
Time frame: one week
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at two weeks
Time frame: two weeks
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at one month
Time frame: one month
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at three months
Time frame: three months
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at six months
Time frame: six months
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at one year
Time frame: one year
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at three years
Time frame: three years
After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL tilt at one week
Time frame: one week
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at two weeks
Time frame: two weeks
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at one month
Time frame: one month
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at three months
Time frame: three months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at six months
Time frame: six months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at one year
Time frame: one year
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at three years
Time frame: three years
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL decentration at one week
Time frame: one week
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
IOL decentration at two weeks
Time frame: two weeks
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
IOL decentration at one month
Time frame: one month
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
IOL decentration at three months
Time frame: three months
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
IOL decentration at six months
Time frame: six months
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
IOL decentration at one year
Time frame: one year
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
IOL decentration at three years
Time frame: three years
Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.
7 secondary outcomes
visual quality at one week
Time frame: one week
visual quality at two weeks
Time frame: two weeks
visual quality at one month
Time frame: one month
visual quality at three months
Time frame: three months
visual quality at six months
Time frame: six months
visual quality at one year
Time frame: one year
visual quality at three years
Time frame: three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jin Yang, PhD principal investigator
Eye & ENT Hospital of Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toric Intraocular Lens Stability and Visual Quality, run by Eye & ENT Hospital of Fudan University at 2 sites 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: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongmei Ma, MD (15629089882, docmdm@163.com), or a site near the patient. 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 24 primary outcomes in all. 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 19 Jun 2025.