Cataract ExtractionNCT04977102
A Randomized Study of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract Patients With Corneal Limbus Opacity
A study testing Intraocular caliper-assisted capsulotomy and Verion navigation system-assisted capsulotomy in people with Cataract Extraction, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality for age-related cataract patients with corneal limbus opacity. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Cataract Extraction
- What is being tested?
- Intraocular caliper-assisted capsulotomy and Verion navigation system-assisted capsulotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Oct 2022
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 55 to 80 years with age-related cataract with pterygium, Corneal geriatric ring, and corneal limbus opacity;
- Pupil diameter ≥ 6.5mm after pupil dilation;
- Lens nuclear opacity grading score (LOCS III) lower than 4.0.
Who cannot join
- Patients had previous intraocular surgery;
- Patients with a diagnosed eye disease that may affect the functions of lens suspensory ligament such as previous ocular trauma, lens subluxation, pseudoexfoliation syndrome, retinal pigment degeneration;
- Patients had other ocular diseases that impair visual function include optic neuropathy, uveitis, and tumor.
- Refused to participate the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, 510060
Xiaoyun Chen, PhD, +86 13632343642, chenxiaoyun@gzzoc.com
About this study
Official title: A Randomized Controlled Trial Comparing Intraocular Caliper-assisted Capsulotomy Versus Verion Navigation System-assisted Capsulotomy for Age-related Cataract With Corneal Limbus Opacity
The purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality for age-related cataract patients with corneal limbus opacity.
Read the detailed description
Continuous curvilinear capsulorhexis (CCC) is an important and technically challenging procedure in cataract surgery. Too large or too small capsulorhexis can increase the incidence of intraoperative and postoperative complications.
In recent years, the image projection device Verion navigation system has been reported that it can improve the repeatability and accuracy of capsulorhexis via projecting a pre-set size ring to guide capsulorhexis. However, we found that for the patients with corneal geriatric ring, pterygium or limbal lesions leading to unclear limbal boundary, the projected capsulorhexis will deviate from the center, resulting in capsulorhexis is off center in clinical practice. Our self-developed intraocular caliper, which is modified on the conventional intraocular irrigation needle, can accurately measure the size of capsulorhexis, and mark the position and boundary of capsulorhexis on the lens anterior capsule to guide capsulorhexis, thus significantly improves the accuracy and centricity of capsulorhexis.
The purpose of this study is to compare the centricity and accuracy of intraocular caliper-assisted capsulorhexis in phacoemulsification for age-related cataract patients with corneal limbus opacity with that of Verion projection navigation system.
- Conditions
- Cataract Extraction
- Being tested
- Intraocular caliper-assisted capsulotomy, Verion navigation system-assisted capsulotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular caliper-assisted capsulotomyProcedure or surgery
Intraocular caliper is a modified intraocular caliper with standard calibration on the rinse needle.
Verion navigation system-assisted capsulotomyProcedure or surgery
Verion Image Guided System (Alcon Laboratories, Inc.) is a digital image guidance system consisting of a diagnostic reference unit and a surgery pilot for intraoperative surgical assistance. The device can be used to align toric intraocular lens during surgery as well as support manual creation of a capsulorhexis with a predefined target diameter.
| Study group | Role | What they receive |
|---|---|---|
| Intraocular caliper-assisted capsulotomy group | Experimental | In intraocular caliper-assisted capsulotomy group, a modified intraocular caliper with standard calibration on the rinse needle was used to measure and locate the position of capsulorhexis with 5.3 mm diameter and the principle of pupillary margin in concentric circles. The surgeon could gently use the blunt needle in the front of the intraocular caliper to further make corresponding markers on the lens anterior capsule, and then carry out capsulotomy according to the marks. Receives: Procedure: Intraocular caliper-assisted capsulotomy |
| Verion navigation system-assisted capsulotomy group | Active comparator | In the Verion-assisted capsulotomy group, Verion navigation system was applied to project a 5.3 mm capsulorhexis centered on the corneal vertex. According to the projected capsulorhexis, capsulotomy was performed. Receives: Procedure: Verion navigation system-assisted capsulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between pupil center and capsulorhexis center
The primary outcome was the distance between pupil center and capsulorhexis center. Clear images of the edges of IOL and capsulorhexis were taken at the end of the operation, and Image J image analysis software is used to measure the distance between pupil center and capsulorhexis center with the diameter of IOL optical surface (6 mm) as the reference by two independently professional graders at the meantime.
Measured: During the surgery
Secondary outcomes (9)
Uncorrected and corrected visual acuity
Evaluated with ETDRS visual acuity chart.
Measured: One month after surgery
Ideal ratio of capsulorhexis
Ideal capsulorhexis is defined as a centered and round capsulorhexis , which can cover the edge of IOL optical surface continuously for 360 degrees with a diameter between 5.0 to 5.5 mm.
Measured: During the surgery
Grades of capsulorhexis-IOL overlap
The capsulorhexis-IOL overlap of each patient was graded as 360-degree continuous overlap, 270~360-degree overlap, 180~270-degree overlap, 90~180-degree overlap, and < 90-degree overlap.
Measured: During the surgery
Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)
Measured by Image J image analysis software.
Measured: During the surgery
Horizontal and vertical diameter of capsulorhexis
Measured by Image J image analysis software.
Measured: During the surgery
Intraocular lens tilt
Measured by anterior segment OCT (CASIA2).
Measured: One month after surgery
Intraocular lens decentration
Measured by anterior segment OCT (CASIA2).
Measured: One month after surgery
Intraocular aberrations
Measured by OPD-SCAN III.
Measured: One month after surgery
Distance between pupil center and capsulorhexis center
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977102
- Sponsor's protocol ID
- 2021KYPJ111
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Intraocular Caliper-assisted Capsulotomy Versus Verion Navigation System-assisted Capsulotomy for Age-related Cataract With Corneal Limbus Opacity
- ClinicalTrials.gov ID
- NCT04977102
- Acronym / sponsor ID
- 2021KYPJ111
- Conditions
- Cataract Extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 26 Jul 2021 (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 purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality for age-related cataract patients with corneal limbus opacity.
Detailed description
Continuous curvilinear capsulorhexis (CCC) is an important and technically challenging procedure in cataract surgery. Too large or too small capsulorhexis can increase the incidence of intraoperative and postoperative complications.
In recent years, the image projection device Verion navigation system has been reported that it can improve the repeatability and accuracy of capsulorhexis via projecting a pre-set size ring to guide capsulorhexis. However, we found that for the patients with corneal geriatric ring, pterygium or limbal lesions leading to unclear limbal boundary, the projected capsulorhexis will deviate from the center, resulting in capsulorhexis is off center in clinical practice. Our self-developed intraocular caliper, which is modified on the conventional intraocular irrigation needle, can accurately measure the size of capsulorhexis, and mark the position and boundary of capsulorhexis on the lens anterior capsule to guide capsulorhexis, thus significantly improves the accuracy and centricity of capsulorhexis.
The purpose of this study is to compare the centricity and accuracy of intraocular caliper-assisted capsulorhexis in phacoemulsification for age-related cataract patients with corneal limbus opacity with that of Verion projection navigation system.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraocular caliper-assisted capsulotomy group | Experimental | Procedure: Intraocular caliper-assisted capsulotomyIn intraocular caliper-assisted capsulotomy group, a modified intraocular caliper with standard calibration on the rinse needle was used to measure and locate the position of capsulorhexis with 5.3 mm diameter and the principle of pupillary margin in concentric circles. The surgeon could gently use the blunt needle in the front of the intraocular caliper to further make corresponding markers on the lens anterior capsule, and then carry out capsulotomy according to the marks. |
| Verion navigation system-assisted capsulotomy group | Active comparator | Procedure: Verion navigation system-assisted capsulotomyIn the Verion-assisted capsulotomy group, Verion navigation system was applied to project a 5.3 mm capsulorhexis centered on the corneal vertex. According to the projected capsulorhexis, capsulotomy was performed. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 55 to 80 years with age-related cataract with pterygium, Corneal geriatric ring, and corneal limbus opacity;
- Pupil diameter ≥ 6.5mm after pupil dilation;
- Lens nuclear opacity grading score (LOCS III) lower than 4.0.
Key exclusion criteria (4 listed)
- Patients had previous intraocular surgery;
- Patients with a diagnosed eye disease that may affect the functions of lens suspensory ligament such as previous ocular trauma, lens subluxation, pseudoexfoliation syndrome, retinal pigment degeneration;
- Patients had other ocular diseases that impair visual function include optic neuropathy, uveitis, and tumor.
- Refused to participate the study.
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 |
|---|---|---|
| Intraocular caliper-assisted capsulotomyIntraocular caliper is a modified intraocular caliper with standard calibration on the rinse needle. | Procedure or surgery | Intraocular caliper-assisted capsulotomy group |
| Verion navigation system-assisted capsulotomyVerion Image Guided System (Alcon Laboratories, Inc.) is a digital image guidance system consisting of a diagnostic reference unit and a surgery pilot for intraoperative surgical assistance. The device can be used to align toric intraocular lens during surgery as well as support manual creation of a capsulorhexis with a predefined target diameter. | Procedure or surgery | Verion navigation system-assisted capsulotomy group |
Primary outcome
Distance between pupil center and capsulorhexis center
Time frame: During the surgery
The primary outcome was the distance between pupil center and capsulorhexis center. Clear images of the edges of IOL and capsulorhexis were taken at the end of the operation, and Image J image analysis software is used to measure the distance between pupil center and capsulorhexis center with the diameter of IOL optical surface (6 mm) as the reference by two independently professional graders at the meantime.
9 secondary outcomes
Uncorrected and corrected visual acuity
Time frame: One month after surgery
Ideal ratio of capsulorhexis
Time frame: During the surgery
Grades of capsulorhexis-IOL overlap
Time frame: During the surgery
Deviation of horizontal and vertical diameter of capsulorhexis from the target diameter (5.3 mm)
Time frame: During the surgery
Horizontal and vertical diameter of capsulorhexis
Time frame: During the surgery
Intraocular lens tilt
Time frame: One month after surgery
Intraocular lens decentration
Time frame: One month after surgery
Intraocular aberrations
Time frame: One month after surgery
Distance between pupil center and capsulorhexis center
Time frame: One month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular caliper-assisted capsulotomy and Verion navigation system-assisted capsulotomy in people with Cataract Extraction, run by Zhongshan Ophthalmic Center, Sun Yat-sen 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 3 inclusion and 4 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 26 Jul 2021. 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?
Contact Xiaoyun Chen, PhD (+86 13632343642, chenxiaoyun@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between pupil center and capsulorhexis center (time frame: During the surgery). 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 26 Jul 2021.