Age-related CataractNCT05028530

Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Ss-oct and Scheimpflug Technology

An observational study of Age-related Cataract, run by Wenzhou Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

To study the correlation between three different lens nuclear opacity classification methods and intraoperative phacoemulsification parameters . Read more about this study

Who is it for?: Any age
Conditions the study is for: Age-related Cataract
How many people: 53 participants
Where: 1 siteChina
Study dates: 1 Oct 2021to 30 Dec 2021
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: In this study, age-related cataract patients who met the criteria for cataract surgery and underwent cataract surgery by the same surgeon in our hospital were included.

Who may be able to join

Age-related cataracts performed by the same surgeon in our hospital;
Pupil diameter can be enlarged more than 6 millimetre.

Who cannot join

The pupil diameter cannot be dilated greater than 6mm;
previously ocular surgery or laser treatment;
history of ocular trauma;
other ocular diseases such as keratoconus, glaucoma and retinal detachment;
corneal opacities caused by leucoma, pterygium and other diseases;
lens dislocation or complicated cataract surgery (any complications during/after the operations);
poor fixation leading to low image quality or inability to cooperate with examinations.

Trial locations and contacts

1 site in 1 country.

Yune Zhao contact

Lulu Chen contact

China1 site

Ophthalmology and Optometry Hospital
Wenzhou, Zhejiang, 325027
zhao yun-e, +86 13819707056

Other trials in China

About this study

Official title: Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Long-range Swept-source Optical Coherence Tomography and Scheimpflug Technology

To study the correlation between three different lens nuclear opacity classification methods and intraoperative phacoemulsification parameters .

Read the detailed description

Slit-lamp lens images, Pentacam and IOL-Master 700 images were collected in patients with dilated pupil before cataract surgery, and phacoemulsification parameters on the Centurion phacoemulsification machine (Alcon) screen were recorded. Spearman correlation analysis was used to analyze the correlation between lens nuclear density and phacoemulsification parameters based on SS-OCT and Scheimpflug techniques.

Conditions: Age-related Cataract
Keywords: cataract, nucleus density, phacoemulsification parameters, ss-oct, scheimpflug
Medical subject headings: Cataract

What is being measured

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

Lens nuclear opalescence(NO) and nuclear colour (NC)
After the maximumly pupil dilation, the same experienced ophthalmologist examined all the eyes with slit-lamp digital cameras in dark conditions and scored the lens nuclear opalescence(NO) and nuclear colour (NC) on a scale of 0.1-6.9 according to LOCS III criteria.
Measured: 2021.12.30
Pentacam mean nuclear density (PND)
After the maximumly pupil dilation, Pentacam HR was used to acquire the Scheimpflug images of the lens, and the average density reading for the entire nucleus provided by PNS function was defined as Pentacam mean nuclear density (PND), ranging from 0% to 100%.
Measured: 2021.12.30
Mean nucleus density (MND) of the lens presented by IOL-Master 700
After the maximumly pupil dilation, the inspected eyes are asked to focus on the indicator light to obtain a high-definition image of the lens. The image is derived to the ImageJ software, and the contour of the lens nucleus is manually drawn. The pixel density of the image within the contour is measured, with a value range of 0-255.The mean pixel density within the region was used to represent the mean nucleus density (MND) of the lens presented by IOL-Master 700.For each eye, the SS-OCT nucleus density is defined as the average of six readings from the corresponding image.
Measured: 2021.12.30
Intraoperative phacoemulsification parameters
The intraoperative phacoemulsification parameters on the Centurion phacoemulsification machine (Alcon) screen were recorded after surgery.
Measured: 2021.12.30

Timeline

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

1 Oct 202130 Dec 2021

First posted31 Aug 2021
Study start1 Oct 2021 (estimated)
Primary completion30 Dec 2021 (estimated)
Study completion30 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Age-related 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: Case only
Time perspective: Cross-sectional
Enrolment: 53 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05028530
Sponsor's protocol ID: LZL nucleus density
Status last verified: Sep 2021
First submitted: 24 Aug 2021
Last updated: 21 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wang W, Zhang J, Gu X, Ruan X, Chen X, Tan X, Jin G, Wang L, He M, Congdon N, Liu Z, Luo L, Liu Y. Objective quantification of lens nuclear opacities using swept-source anterior segment optical coherence tomography. Br J Ophthalmol. 2022 Jun;106(6):790-794. doi: 10.1136/bjophthalmol-2020-318334. Epub 2021 Jan 13.
PubMed 33441322
Makhotkina NY, Berendschot TTJM, van den Biggelaar FJHM, Weik ARH, Nuijts RMMA. Comparability of subjective and objective measurements of nuclear density in cataract patients. Acta Ophthalmol. 2018 Jun;96(4):356-363. doi: 10.1111/aos.13694. Epub 2018 Mar 25.
PubMed 29575599
Lim SA, Shin JY, Chung SH. Useful Prediction of Phacodynamics by Scheimpflug Lens Densitometry in Patients over Age 70. Semin Ophthalmol. 2017;32(4):482-487. doi: 10.3109/08820538.2015.1120756. Epub 2016 Apr 19.
PubMed 27092580
Gupta M, Ram J, Jain A, Sukhija J, Chaudhary M. Correlation of nuclear density using the Lens Opacity Classification System III versus Scheimpflug imaging with phacoemulsification parameters. J Cataract Refract Surg. 2013 Dec;39(12):1818-23. doi: 10.1016/j.jcrs.2013.05.052.
PubMed 24286839
Chen D, Li Z, Huang J, Yu L, Liu S, Zhao YE. Lens nuclear opacity quantitation with long-range swept-source optical coherence tomography: correlation to LOCS III and a Scheimpflug imaging-based grading system. Br J Ophthalmol. 2019 Aug;103(8):1048-1053. doi: 10.1136/bjophthalmol-2018-312661. Epub 2018 Oct 12.
PubMed 30315132
Panthier C, de Wazieres A, Rouger H, Moran S, Saad A, Gatinel D. Average lens density quantification with swept-source optical coherence tomography: optimized, automated cataract grading technique. J Cataract Refract Surg. 2019 Dec;45(12):1746-1752. doi: 10.1016/j.jcrs.2019.07.033.
PubMed 31856985
Panthier C, Burgos J, Rouger H, Saad A, Gatinel D. New objective lens density quantification method using swept-source optical coherence tomography technology: Comparison with existing methods. J Cataract Refract Surg. 2017 Dec;43(12):1575-1581. doi: 10.1016/j.jcrs.2017.09.028.
PubMed 29335103

Want to know more?

Yune Zhao

8613819707056

zyehzeye@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Age-related Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Long-range Swept-source Optical Coherence Tomography and Scheimpflug Technology
ClinicalTrials.gov ID: NCT05028530
Acronym / sponsor ID: LZL nucleus density
Conditions: Age-related Cataract
Keywords: cataract, nucleus density, phacoemulsification parameters, ss-oct, scheimpflug
Study type: Observational
Recruitment status: Unknown status
Enrolment: 53 participants (estimated)
Lead sponsor: Wenzhou Medical UniversityUniversity, hospital or other
Study start: 1 Oct 2021 (estimated)
Primary completion: 30 Dec 2021 (estimated)
Study completion: 30 Dec 2021 (estimated)
First posted: 31 Aug 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.

To study the correlation between three different lens nuclear opacity classification methods and intraoperative phacoemulsification parameters .

Detailed description

Study design

Observational model: Case only
Time perspective: Cross-sectional

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: In this study, age-related cataract patients who met the criteria for cataract surgery and underwent cataract surgery by the same surgeon in our hospital were included.

Key inclusion criteria (2 listed)

Age-related cataracts performed by the same surgeon in our hospital;
Pupil diameter can be enlarged more than 6 millimetre.

Key exclusion criteria (7 listed)

The pupil diameter cannot be dilated greater than 6mm;
previously ocular surgery or laser treatment;
history of ocular trauma;
other ocular diseases such as keratoconus, glaucoma and retinal detachment;
corneal opacities caused by leucoma, pterygium and other diseases;

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

Lens nuclear opalescence(NO) and nuclear colour (NC)
Time frame: 2021.12.30
After the maximumly pupil dilation, the same experienced ophthalmologist examined all the eyes with slit-lamp digital cameras in dark conditions and scored the lens nuclear opalescence(NO) and nuclear colour (NC) on a scale of 0.1-6.9 according to LOCS III criteria.
Pentacam mean nuclear density (PND)
Time frame: 2021.12.30
After the maximumly pupil dilation, Pentacam HR was used to acquire the Scheimpflug images of the lens, and the average density reading for the entire nucleus provided by PNS function was defined as Pentacam mean nuclear density (PND), ranging from 0% to 100%.
Mean nucleus density (MND) of the lens presented by IOL-Master 700
Time frame: 2021.12.30
After the maximumly pupil dilation, the inspected eyes are asked to focus on the indicator light to obtain a high-definition image of the lens. The image is derived to the ImageJ software, and the contour of the lens nucleus is manually drawn. The pixel density of the image within the contour is measured, with a value range of 0-255.The mean pixel density within the region was used to represent the mean nucleus density (MND) of the lens presented by IOL-Master 700.For each eye, the SS-OCT nucleus density is defined as the average of six readings from the corresponding image.
Intraoperative phacoemulsification parameters
Time frame: 2021.12.30
The intraoperative phacoemulsification parameters on the Centurion phacoemulsification machine (Alcon) screen were recorded after surgery.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Background: PubMed 33441322Wang W, Zhang J, Gu X, Ruan X, Chen X, Tan X, Jin G, Wang L, He M, Congdon N, Liu Z, Luo L, Liu Y. Objective quantification of lens nuclear opacities using swept-source anterior segment optical coherence tomography. Br J Ophthalmol. 2022 Jun;106(6):790-794. doi: 10.1136/bjophthalmol-2020-318334. Epub 2021 Jan 13.
Background: PubMed 29575599Makhotkina NY, Berendschot TTJM, van den Biggelaar FJHM, Weik ARH, Nuijts RMMA. Comparability of subjective and objective measurements of nuclear density in cataract patients. Acta Ophthalmol. 2018 Jun;96(4):356-363. doi: 10.1111/aos.13694. Epub 2018 Mar 25.
Background: PubMed 27092580Lim SA, Shin JY, Chung SH. Useful Prediction of Phacodynamics by Scheimpflug Lens Densitometry in Patients over Age 70. Semin Ophthalmol. 2017;32(4):482-487. doi: 10.3109/08820538.2015.1120756. Epub 2016 Apr 19.
Background: PubMed 24286839Gupta M, Ram J, Jain A, Sukhija J, Chaudhary M. Correlation of nuclear density using the Lens Opacity Classification System III versus Scheimpflug imaging with phacoemulsification parameters. J Cataract Refract Surg. 2013 Dec;39(12):1818-23. doi: 10.1016/j.jcrs.2013.05.052.
Background: PubMed 30315132Chen D, Li Z, Huang J, Yu L, Liu S, Zhao YE. Lens nuclear opacity quantitation with long-range swept-source optical coherence tomography: correlation to LOCS III and a Scheimpflug imaging-based grading system. Br J Ophthalmol. 2019 Aug;103(8):1048-1053. doi: 10.1136/bjophthalmol-2018-312661. Epub 2018 Oct 12.
Background: PubMed 31856985Panthier C, de Wazieres A, Rouger H, Moran S, Saad A, Gatinel D. Average lens density quantification with swept-source optical coherence tomography: optimized, automated cataract grading technique. J Cataract Refract Surg. 2019 Dec;45(12):1746-1752. doi: 10.1016/j.jcrs.2019.07.033.
Background: PubMed 29335103Panthier C, Burgos J, Rouger H, Saad A, Gatinel D. New objective lens density quantification method using swept-source optical coherence tomography technology: Comparison with existing methods. J Cataract Refract Surg. 2017 Dec;43(12):1575-1581. doi: 10.1016/j.jcrs.2017.09.028.

Related trials for Age-related Cataract

Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Recruiting
Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice
Vision Impairment and Blindness, Glaucoma
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
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Active, not recruitingObservational study
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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.

Yune Zhao contact

Lulu Chen contact

Yune Zhao study director

Ophthalmology and Optometry 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 Age-related Cataract, run by Wenzhou Medical 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 2 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: status not confirmed, as of the sponsor's last update on 21 Sep 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 Yune Zhao (8613819707056, zyehzeye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lens nuclear opalescence(NO) and nuclear colour (NC) (time frame: 2021.12.30). The study lists 4 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 NCT05028530, which also lists 7 linked publications.

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 21 Sep 2021.