CataractNCT06590272
Comparison on Outcomes of Four IOLs in Patients With Cataracts
An observational study of Cataract and Intraocular Lens, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Cataract, Intraocular Lens, Visual Outcomes
- What is being tested?
- TECNIS PCB00 intraocular lens, HumanOptics Diff-Aay intraocular lens and TECNIS Symfony ZXR00 intraocular len
- Type of treatment
- Medical device
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Jun 2023
- 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cataract ultrasonic emulsification aspiration with one-stage implantation of 4 types of IOLs at the Shanghai Tenth People\'s Hospital from October 2021 to June 2023
Who may be able to join
- age-related cataract with myopia≤-6.0D and over 0.0D
- axial length≤26mm and corneal astigmatism≤1.5D
- well-cooperation of finishing preoperative examinations
- completion of all follow-up visits
Who cannot join
- previous eye diseases that affect vision including keratopathy, glaucoma, uveitis, amblyopia, fundus diseases, etc.
- patients with decreased cognitive ability, unable to cooperate with preoperative examination, or suffering from severe anxiety, depression and mental illness
- serious complications during operation, including corneal injury, iris injury, expelling choroidal hemorrhage, posterior capsule rupture, etc
- serious postoperative complications, including displacement of intraocular lens, macular edema, endophthalmitis, etc
- follow-ups less than 3months
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Comparison on Visual and Refractive Outcomes of Four Different Types of IOL in Patients With Cataracts
The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into 4 groups. Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.
Read the detailed description
The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into group A (TECNIS PCB00 IOL), Group B (HumanOptics Diff-Aay IOL), Group C (TECNIS Symfony ZXR00 IOL) and group D (ZEISS AT LISA tri 839MP IOL). Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.
- Conditions
- Cataract, Intraocular Lens, Visual Outcomes
- Being tested
- TECNIS PCB00 intraocular lens, HumanOptics Diff-Aay intraocular lens, TECNIS Symfony ZXR00 intraocular len, ZEISS AT LISA tri 839MP intraocular len
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECNIS PCB00 intraocular lensDevice
Also called IOL
In this study, we select TECNIS PCB00 IOL for inserting in the eyes during the cataract surgery
HumanOptics Diff-Aay intraocular lensDevice
Also called IOL
In this study, we select HumanOptics Diff-Aay IOL for inserting in the eyes during the cataract surgery
TECNIS Symfony ZXR00 intraocular lenDevice
Also called IOL
In this study, we select TECNIS Symfony ZXR00 IOL for inserting in the eyes during the cataract surgery
ZEISS AT LISA tri 839MP intraocular lenDevice
Also called IOL
In this study, we select ZEISS AT LISA tri 839MP IOL for inserting in the eyes during the cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| TECNIS PCB00 IOL (A) | The patients in this groups underwent cataract surgery with TECNIS PCB00 IOL Receives: Device: TECNIS PCB00 intraocular lens | |
| HumanOptics Diff-Aay IOL (B) | The patients in this groups underwent cataract surgery with HumanOptics Diff-Aay IOL Receives: Device: HumanOptics Diff-Aay intraocular lens | |
| TECNIS Symfony ZXR00 IOL (C) | The patients in this groups underwent cataract surgery with TECNIS Symfony ZXR00 IOL Receives: Device: TECNIS Symfony ZXR00 intraocular len | |
| ZEISS AT LISA tri 839MP IOL (D) | The patients in this groups underwent cataract surgery with ZEISS AT LISA tri 839MP IOL Receives: Device: ZEISS AT LISA tri 839MP intraocular len |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative visual acuity
The uncorrected distant visual acuity(UDVA), the best corrected distant visual acuity (BCVA) (5 m), the uncorrected intermediate visual acuity(UIVA) (80 cm) and the uncorrected near visual acuity(UIVA) (40 cm) were chosen as the index to evaluate the VA. The UDVA and BCVA were examined by logarithmic visual acuity chart. The UIVA and UIVA were examined by using a near eye chart.They were all measured 1 month and 3 months after the surgery.
Measured: 3 months
Postoperative contrast sensitivity
The contrast sensitivity was used to conduct the assessment by CSV-1000E (VectorVision, USA) under photopic (85 cd/m2) condition at a 2.5m distance. The logarithmic values for 3, 6, 12, and 18 cycles/degree (c/d) were analyzed 3 months postoperatively.
Measured: 3 months
Postoperative defocus curve
Defocus curve was used to evaluate the visual quality of functional intraocular lens after surgery. The insertion range was -4.0 D ~ + 2.0 D, increasing by 0.5 D. The best corrected distant visual acuity was recorded at each diopter 3 months postoperatively.
Measured: 3 months
Postoperative eye-related quality of life
Based on the American Questionnaire on Visual Function Index-14 (VF-14), the Chinese-oriented version(VF-12-CN) was used to investigate the postoperative near-vision, visual satisfaction, ocular discomfort, visual disturbance, and subjective feelings of far-vision, middle-vision and near-vision. Each question was divided into 4 levels and the scores ranked from 0 to 3 points. Considering the visual interference such as glare and halo, the evaluation of glare and halo visual interference phenomenon was also added.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yilin, Shanghai 10th People's Hospital
- Investigators
- Yiwen Hu, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590272
- Sponsor's protocol ID
- SHSY-LYZX-210
- Status last verified
- Sep 2024
- First submitted
- 31 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison on Visual and Refractive Outcomes of Four Different Types of IOL in Patients With Cataracts
- ClinicalTrials.gov ID
- NCT06590272
- Acronym / sponsor ID
- SHSY-LYZX-210
- Conditions
- Cataract, Intraocular Lens, Visual Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Sep 2024 (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 objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into 4 groups. Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.
Detailed description
The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into group A (TECNIS PCB00 IOL), Group B (HumanOptics Diff-Aay IOL), Group C (TECNIS Symfony ZXR00 IOL) and group D (ZEISS AT LISA tri 839MP IOL). Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TECNIS PCB00 IOL (A) | – | Device: TECNIS PCB00 intraocular lensThe patients in this groups underwent cataract surgery with TECNIS PCB00 IOL |
| HumanOptics Diff-Aay IOL (B) | – | Device: HumanOptics Diff-Aay intraocular lensThe patients in this groups underwent cataract surgery with HumanOptics Diff-Aay IOL |
| TECNIS Symfony ZXR00 IOL (C) | – | Device: TECNIS Symfony ZXR00 intraocular lenThe patients in this groups underwent cataract surgery with TECNIS Symfony ZXR00 IOL |
| ZEISS AT LISA tri 839MP IOL (D) | – | Device: ZEISS AT LISA tri 839MP intraocular lenThe patients in this groups underwent cataract surgery with ZEISS AT LISA tri 839MP IOL |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cataract ultrasonic emulsification aspiration with one-stage implantation of 4 types of IOLs at the Shanghai Tenth People\'s Hospital from October 2021 to June 2023
Key inclusion criteria (4 listed)
- age-related cataract with myopia≤-6.0D and over 0.0D
- axial length≤26mm and corneal astigmatism≤1.5D
- well-cooperation of finishing preoperative examinations
- completion of all follow-up visits
Key exclusion criteria (5 listed)
- previous eye diseases that affect vision including keratopathy, glaucoma, uveitis, amblyopia, fundus diseases, etc.
- patients with decreased cognitive ability, unable to cooperate with preoperative examination, or suffering from severe anxiety, depression and mental illness
- serious complications during operation, including corneal injury, iris injury, expelling choroidal hemorrhage, posterior capsule rupture, etc
- serious postoperative complications, including displacement of intraocular lens, macular edema, endophthalmitis, etc
- follow-ups less than 3months
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 |
|---|---|---|
| TECNIS PCB00 intraocular lensAlso: IOLIn this study, we select TECNIS PCB00 IOL for inserting in the eyes during the cataract surgery | Device | TECNIS PCB00 IOL (A) |
| HumanOptics Diff-Aay intraocular lensAlso: IOLIn this study, we select HumanOptics Diff-Aay IOL for inserting in the eyes during the cataract surgery | Device | HumanOptics Diff-Aay IOL (B) |
| TECNIS Symfony ZXR00 intraocular lenAlso: IOLIn this study, we select TECNIS Symfony ZXR00 IOL for inserting in the eyes during the cataract surgery | Device | TECNIS Symfony ZXR00 IOL (C) |
| ZEISS AT LISA tri 839MP intraocular lenAlso: IOLIn this study, we select ZEISS AT LISA tri 839MP IOL for inserting in the eyes during the cataract surgery | Device | ZEISS AT LISA tri 839MP IOL (D) |
Primary outcome
Postoperative visual acuity
Time frame: 3 months
The uncorrected distant visual acuity(UDVA), the best corrected distant visual acuity (BCVA) (5 m), the uncorrected intermediate visual acuity(UIVA) (80 cm) and the uncorrected near visual acuity(UIVA) (40 cm) were chosen as the index to evaluate the VA. The UDVA and BCVA were examined by logarithmic visual acuity chart. The UIVA and UIVA were examined by using a near eye chart.They were all measured 1 month and 3 months after the surgery.
Postoperative contrast sensitivity
Time frame: 3 months
The contrast sensitivity was used to conduct the assessment by CSV-1000E (VectorVision, USA) under photopic (85 cd/m2) condition at a 2.5m distance. The logarithmic values for 3, 6, 12, and 18 cycles/degree (c/d) were analyzed 3 months postoperatively.
Postoperative defocus curve
Time frame: 3 months
Defocus curve was used to evaluate the visual quality of functional intraocular lens after surgery. The insertion range was -4.0 D ~ + 2.0 D, increasing by 0.5 D. The best corrected distant visual acuity was recorded at each diopter 3 months postoperatively.
Postoperative eye-related quality of life
Time frame: 3 months after surgery
Based on the American Questionnaire on Visual Function Index-14 (VF-14), the Chinese-oriented version(VF-12-CN) was used to investigate the postoperative near-vision, visual satisfaction, ocular discomfort, visual disturbance, and subjective feelings of far-vision, middle-vision and near-vision. Each question was divided into 4 levels and the scores ranked from 0 to 3 points. Considering the visual interference such as glare and halo, the evaluation of glare and halo visual interference phenomenon was also added.
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 19 Sep 2024.
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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.
Yiwen Hu principal investigator
Shanghai 10th People's 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 Cataract and Intraocular Lens, run by Shanghai 10th People's Hospital 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 5 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 19 Sep 2024. 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?
Postoperative visual acuity (time frame: 3 months). 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?
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 Sep 2024.