CataractNCT06505434
A Dynamic Study of Pupil Diameter After Artificial Lens Implantation in Patients With High Myopia
An observational study of Cataract, run by Shanghai Eye Disease Prevention and Treatment Center.
Trial summary
Age-related cataract remains the leading cause of blindness in developing countries. And, with the aging of the population in these countries, the number of cataract patients will continue to grow. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Jan 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sixty patients (120 eyes) with high myopia who underwent binocular sequential lens ultrasonoemulsification combined with monofocal IOL implantation surgery for treatment of high myopia in our hospital were selected.
Who may be able to join
- a diagnosis of myopia: equivalent spherical lens extent (SE) SE ≤ -0.0 D when the eye is relaxed in accommodation; (2) a diagnosis of cataract; (3) surgical treatment with sequential lens ultrasonoemulsification combined with monofocal IOL implantation in both eyes at our hospital; and (4) consent to participate and cooperate in this study.
Who cannot join
- Symptoms of acute eye diseases, such as eye redness, eye pain, and increased eye discharge; (2) Other binocular eye diseases that seriously affect visual function, such as amblyopia, glaucoma, diabetic retinopathy, severe age-related macular degeneration and retinal detachment; (3) Intra-operative or post-operative complications from cataract surgery; combined with other ophthalmologic surgeries; and any other ophthalmologic surgeries in both eyes during the follow-up period; (4) History of injuries; (5) Inability to understand the informed consent; and (6) Inability to communicate. ) history of trauma; (5) inability to understand the informed consent form and inability to communicate.
About this study
Age-related cataract remains the leading cause of blindness in developing countries. And, with the aging of the population in these countries, the number of cataract patients will continue to grow. With accurate biological measurements and the implantation of appropriate IOLs, most cataract patients can achieve good distance vision after surgery. However, it should not be overlooked that the current global prevalence of myopia is over 28.3% and is expected to reach 49.8% by 2050, while the rate of high myopia will increase from the current 4.0% to 9.8%. The prevalence of cataracts is significantly higher in the highly myopic population than in the orthoptic population.
The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL. It has been shown that the diameter and sensitivity of the pupil in patients with high myopia are also significantly different from those in the orthopneic population, and that there is a correlation with the adjustment status and refractive error. The purpose of this study is to investigate the following: 1. Whether the change of refractive status before and after IOL implantation in highly myopic cataract patients will lead to the change of pupil physiological characteristics, and whether the modification of preoperative measurement parameters can expand the population of myopic patients who can be reasonably applied to the functional IOL and obtain a high degree of satisfaction from patients. 2. Pupil diameter under a single fixed light source is a rough assessment for the screening of the population for functional IOLs, and this study was conducted in a single fixed light source. In this study, we measured the maximum value of pupil diameter, minimum value of pupil diameter, and rate of change of pupil diameter under bright vision and dark vision, and analyzed the correlation between the above three parameters and visual quality to further optimize the objective index of pupil diameter for the screening of functional IOL applicants.
Read more
Objectives of the study
- To observe the dynamic changes of pupil diameter and its visual quality before and after lens extraction combined with IOL implantation in myopic patients, and to analyze the correlation between the changes of pupil diameter and visual quality;
- To explore the patterns of refractive error and pupil biometric changes in myopic patients before and after IOL implantation, and to make corrections for the evaluation of preoperative biometric indexes for reference.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Keywords
- cataract, high myopia
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Phaco + IOL Implantation
| Study group | Role | What they receive |
|---|---|---|
| Low myopia group | A low myopia group (0D to -6.0D) Receives: Procedure: Cataract surgery | |
| high myopia group | B high myopia group (-6.0 to -12.0D) Receives: Procedure: Cataract surgery | |
| ultra-high myopia group | C ultra-high myopia group (greater than -12.0D) group Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupil size
pupil size before and after surgery
Measured: 1 week ,1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
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
- Case only
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505434
- Sponsor's protocol ID
- QX-2023-A-011
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dynamic Study of Pupil Diameter After Artificial Lens Implantation in Patients With High Myopia
- ClinicalTrials.gov ID
- NCT06505434
- Acronym / sponsor ID
- QX-2023-A-011
- Conditions
- Cataract
- Keywords
- cataract, high myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 17 Jul 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.
Age-related cataract remains the leading cause of blindness in developing countries. And, with the aging of the population in these countries, the number of cataract patients will continue to grow. With accurate biological measurements and the implantation of appropriate IOLs, most cataract patients can achieve good distance vision after surgery. However, it should not be overlooked that the current global prevalence of myopia is over 28.3% and is expected to reach 49.8% by 2050, while the rate of high myopia will increase from the current 4.0% to 9.8%. The prevalence of cataracts is significantly higher in the highly myopic population than in the orthoptic population.
The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL. It has been shown that the diameter and sensitivity of the pupil in patients with high myopia are also significantly different from those in the orthopneic population, and that there is a correlation with the adjustment status and refractive error. The purpose of this study is to investigate the following: 1. Whether the change of refractive status before and after IOL implantation in highly myopic cataract patients will lead to the change of pupil physiological characteristics, and whether the modification of preoperative measurement parameters can expand the population of myopic patients who can be reasonably applied to the functional IOL and obtain a high degree of satisfaction from patients. 2. Pupil diameter under a single fixed light source is a rough assessment for the screening of the population for functional IOLs, and this study was conducted in a single fixed light source. In this study, we measured the maximum value of pupil diameter, minimum value of pupil diameter, and rate of change of pupil diameter under bright vision and dark vision, and analyzed the correlation between the above three parameters and visual quality to further optimize the objective index of pupil diameter for the screening of functional IOL applicants.
Objectives of the study
- To observe the dynamic changes of pupil diameter and its visual quality before and after lens extraction combined with IOL implantation in myopic patients, and to analyze the correlation between the changes of pupil diameter and visual quality;
- To explore the patterns of refractive error and pupil biometric changes in myopic patients before and after IOL implantation, and to make corrections for the evaluation of preoperative biometric indexes for reference.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low myopia group | – | Procedure: Cataract surgeryA low myopia group (0D to -6.0D) |
| high myopia group | – | Procedure: Cataract surgeryB high myopia group (-6.0 to -12.0D) |
| ultra-high myopia group | – | Procedure: Cataract surgeryC ultra-high myopia group (greater than -12.0D) group |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty patients (120 eyes) with high myopia who underwent binocular sequential lens ultrasonoemulsification combined with monofocal IOL implantation surgery for treatment of high myopia in our hospital were selected.
Key inclusion criteria (1 listed)
- a diagnosis of myopia: equivalent spherical lens extent (SE) SE ≤ -0.0 D when the eye is relaxed in accommodation; (2) a diagnosis of cataract; (3) surgical treatment with sequential lens ultrasonoemulsification combined with monofocal IOL implantation in both eyes at our hospital; and (4) consent to participate and cooperate in this study.
Key exclusion criteria (1 listed)
- Symptoms of acute eye diseases, such as eye redness, eye pain, and increased eye discharge; (2) Other binocular eye diseases that seriously affect visual function, such as amblyopia, glaucoma, diabetic retinopathy, severe age-related macular degeneration and retinal detachment; (3) Intra-operative or post-operative complications from cataract surgery; combined with other ophthalmologic surgeries; and any other ophthalmologic surgeries in both eyes during the follow-up period; (4) History of injuries; (5) Inability to understand the informed consent; and (6) Inability to communicate. ) history of trauma; (5) inability to understand the informed consent form and inability to communicate.
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 |
|---|---|---|
| Cataract surgeryPhaco + IOL Implantation | Procedure or surgery | Low myopia group, high myopia group, ultra-high myopia group |
Primary outcome
pupil size
Time frame: 1 week ,1 month, 3 months
pupil size before and after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Shanghai Eye Disease Prevention and Treatment Center.
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 1 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
pupil size (time frame: 1 week ,1 month, 3 months). 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 17 Jul 2024.