CataractNCT04839250
Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
A study testing heads-up method in people with Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- heads-up method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Oct 2021
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnose age-related cataract;
- Plan to perform phacoemulsification of cataract with intraocular lens implantation;
- Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;
- Able to understand and independently fill in the informed consent form and postoperative follow-up plan.
Who cannot join
- Cataract caused by other reasons;
- Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;
- Corneal diseases, corneal endothelial cells <1800/mm2;
- Small palpebral fissure;
- Those with a history of glaucoma, uveitis, eye trauma or eye surgery;
- Those who cannot cooperate with the inspection and have not completed the one-month follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery
Read the detailed description
To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery.Prospective research.One eligible eye from patients having cataract surgery performed using the 3-D head-up technique were included in the study as an experimental group,in the meanwhile eyes performed cataract surgery by traditional microsurgery included as a control group.All eyes in the study are operated by the same doctor. Corneal incision form,corneal endothelial cell density and best corrected visual acuity are included to evaluate the results of cataract surgery.
- Conditions
- Cataract
- Being tested
- heads-up method
- Keywords
- three-dimensional surgery, microsurgery, phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heads-up methodProcedure or surgery
3D surgical video system, which includes Alcon NGENUITY 3D visualization system (Alcon, Fort Worth, TX) and Leica M822 and M844 microscopes (Leica Microsystems, Wetzlar, Germany),can be used to perform head-up phacoemulsification combined with intraocular lens implantation surgery.
| Study group | Role | What they receive |
|---|---|---|
| cataract surgery performed by heads-up method | Experimental | 3D heads-up surgery was performed under the NGENUITY® 3D visualization system Receives: Procedure: heads-up method |
| Traditional surgery | No intervention | Traditional surgery was performed under a surgical microscope. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of corneal incision from 1day after surgery to 1 months
the shape and length of the corneal incision ，if descemet's layer detachment happens
Measured: up to 1day,1week,1 month
corneal endothelial cell density
the number of corneal endothelial cells per unit area
Measured: up to 1 month
Secondary outcomes (3)
best corrected visual acuity
best corrected visual acuity
Measured: up to 1 month
change from baseline central corneal thickness at 1 months
thickness in micrometer
Measured: up to 1 day,1 week,1 month
change from baseline corneal incision thickness at 1 months
Thickness of corneal incision
Measured: up to 1 day,1 week,1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Feb 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839250
- Sponsor's protocol ID
- 3D system-CPJ
- Status last verified
- May 2022
- First submitted
- 4 Apr 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu Z, Chang P, Huang F, Shen S, Zhao X, Ji X, Zhao YE. Comparison of Three-Dimensional Surgical System Versus Binocular Microscope for Clear Corneal Incision in Cataract Surgery. Ophthalmol Ther. 2022 Aug;11(4):1589-1600. doi: 10.1007/s40123-022-00537-4. Epub 2022 Jun 24.
PubMed 35749016
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
- ClinicalTrials.gov ID
- NCT04839250
- Acronym / sponsor ID
- 3D system-CPJ
- Conditions
- Cataract
- Keywords
- three-dimensional surgery, microsurgery, phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 9 Apr 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 evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery
Detailed description
To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery.Prospective research.One eligible eye from patients having cataract surgery performed using the 3-D head-up technique were included in the study as an experimental group,in the meanwhile eyes performed cataract surgery by traditional microsurgery included as a control group.All eyes in the study are operated by the same doctor. Corneal incision form,corneal endothelial cell density and best corrected visual acuity are included to evaluate the results of cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cataract surgery performed by heads-up method | Experimental | Procedure: heads-up method3D heads-up surgery was performed under the NGENUITY® 3D visualization system |
| Traditional surgery | No intervention | –Traditional surgery was performed under a surgical microscope. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnose age-related cataract;
- Plan to perform phacoemulsification of cataract with intraocular lens implantation;
- Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;
- Able to understand and independently fill in the informed consent form and postoperative follow-up plan.
Key exclusion criteria (6 listed)
- Cataract caused by other reasons;
- Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;
- Corneal diseases, corneal endothelial cells <1800/mm2;
- Small palpebral fissure;
- Those with a history of glaucoma, uveitis, eye trauma or eye 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 |
|---|---|---|
| heads-up method3D surgical video system, which includes Alcon NGENUITY 3D visualization system (Alcon, Fort Worth, TX) and Leica M822 and M844 microscopes (Leica Microsystems, Wetzlar, Germany),can be used to perform head-up phacoemulsification combined with intraocular lens implantation surgery. | Procedure or surgery | cataract surgery performed by heads-up method |
Primary outcome
change of corneal incision from 1day after surgery to 1 months
Time frame: up to 1day,1week,1 month
the shape and length of the corneal incision ，if descemet's layer detachment happens
corneal endothelial cell density
Time frame: up to 1 month
the number of corneal endothelial cells per unit area
3 secondary outcomes
best corrected visual acuity
Time frame: up to 1 month
change from baseline central corneal thickness at 1 months
Time frame: up to 1 day,1 week,1 month
change from baseline corneal incision thickness at 1 months
Time frame: up to 1 day,1 week,1 month
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 12 May 2022.
- Derived from this study: PubMed 35749016Zhu Z, Chang P, Huang F, Shen S, Zhao X, Ji X, Zhao YE. Comparison of Three-Dimensional Surgical System Versus Binocular Microscope for Clear Corneal Incision in Cataract Surgery. Ophthalmol Ther. 2022 Aug;11(4):1589-1600. doi: 10.1007/s40123-022-00537-4. Epub 2022 Jun 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heads-up method in people with 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 4 inclusion and 6 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 12 May 2022. 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?
change of corneal incision from 1day after surgery to 1 months (time frame: up to 1day,1week,1 month). The study lists 2 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 NCT04839250, 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 12 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.