CataractNCT06505096
A Comparative Study of the Results of Dynamic and OPD Static Measurement of Pupil Diameter Before and After Cataract Surgery by Pupil Detectors
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 eyes of patients who were treated with lens ultrasonic emulsification combined with IOL implantation in our hospital were selected. According to the preoperative refractive status, they were divided into orthokeratology group (-0.5D~+0.5D), myopia group less than -0.5D, hyperopia group more than +0.5D, 20 eyes in each group.
Who may be able to join
- diagnosed with cataract; (2) treated with lens ultrasonic emulsification combined with monofocal IOL implantation in our hospital; (3) agreed to participate and cooperate with this study.
Who cannot join
- acute eye disease symptoms, such as eye redness, eye pain, increased ocular secretions, etc.; (2) other eye diseases that seriously affect visual function in both eyes, such as amblyopia, high myopia, glaucoma, diabetic retinopathy, severe age-related macular degeneration and retinal detachment, etc.; (3) intra-operative or post-operative complications in cataract surgery; combined with other ophthalmic surgeries; and any other ophthalmic surgery for both eyes in the follow-up period; the presence of any other ophthalmic surgery in both eyes in the follow-up period. (4) 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 a suitable IOL, most cataract patients can achieve good distance vision after surgery. Studies have shown differences in pupil diameter and sensitivity in patients with different refractive states, with correlations to accommodation status as well as refractive error. The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL.
Among the various instruments used for preoperative cataract biological measurements, the light source is mostly a fixed parameter, and the static pupil diameter measurement by fixed illumination light source detection as an evaluation method is relatively rough. In this study, we are going to simulate different illumination states in daily life and set up two kinds of measurement instruments, namely, OPD and binocular pupil detector, so as to obtain more realistic research results and to explore the following: 1. The static and dynamic measurement of pupil diameter by people of different refractive states in different periods of preoperative and postoperative period. 2. Whether there is a difference between the static and dynamic pupil measurement results, 2. the change of pupil size under the stimulation of different light sources, and to compare the difference between the two detection methods, to provide objective pupil indexes for the more scientific selection of functional IOLs, to provide a basis for the selection of more accurate pupil measurement methods, to accurately screen the population of the use of functional IOLs, and to improve the patient's satisfaction after the operation.
Purpose of the study To simulate the difference between the preoperative and postoperative pupil diameters of cataract patients measured by static and dynamic methods under daily illumination, to select a more accurate pupil measurement method, and to make corrections for the evaluation of preoperative biometric indexes.
- Conditions
- Cataract
- Being tested
- cataract surgery
- Keywords
- cataract, pupil size
- 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 implention
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology group | -0.5D~+0.0D Receives: Procedure: cataract surgery | |
| myopia group | SE lens less than -0.5D Receives: Procedure: cataract surgery | |
| hyperopia group | SE more than +0.5D 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 cataract 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
- NCT06505096
- Sponsor's protocol ID
- QX-2023-A-012
- 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 Comparative Study of the Results of Dynamic and OPD Static Measurement of Pupil Diameter Before and After Cataract Surgery by Pupil Detectors
- ClinicalTrials.gov ID
- NCT06505096
- Acronym / sponsor ID
- QX-2023-A-012
- Conditions
- Cataract
- Keywords
- cataract, pupil size
- 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 a suitable IOL, most cataract patients can achieve good distance vision after surgery. Studies have shown differences in pupil diameter and sensitivity in patients with different refractive states, with correlations to accommodation status as well as refractive error. The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL.
Among the various instruments used for preoperative cataract biological measurements, the light source is mostly a fixed parameter, and the static pupil diameter measurement by fixed illumination light source detection as an evaluation method is relatively rough. In this study, we are going to simulate different illumination states in daily life and set up two kinds of measurement instruments, namely, OPD and binocular pupil detector, so as to obtain more realistic research results and to explore the following: 1. The static and dynamic measurement of pupil diameter by people of different refractive states in different periods of preoperative and postoperative period. 2. Whether there is a difference between the static and dynamic pupil measurement results, 2. the change of pupil size under the stimulation of different light sources, and to compare the difference between the two detection methods, to provide objective pupil indexes for the more scientific selection of functional IOLs, to provide a basis for the selection of more accurate pupil measurement methods, to accurately screen the population of the use of functional IOLs, and to improve the patient's satisfaction after the operation.
Purpose of the study To simulate the difference between the preoperative and postoperative pupil diameters of cataract patients measured by static and dynamic methods under daily illumination, to select a more accurate pupil measurement method, and to make corrections for the evaluation of preoperative biometric indexes.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology group | – | Procedure: cataract surgery-0.5D~+0.0D |
| myopia group | – | Procedure: cataract surgerySE lens less than -0.5D |
| hyperopia group | – | Procedure: cataract surgerySE more than +0.5D |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty eyes of patients who were treated with lens ultrasonic emulsification combined with IOL implantation in our hospital were selected. According to the preoperative refractive status, they were divided into orthokeratology group (-0.5D~+0.5D), myopia group less than -0.5D, hyperopia group more than +0.5D, 20 eyes in each group.
Key inclusion criteria (1 listed)
- diagnosed with cataract; (2) treated with lens ultrasonic emulsification combined with monofocal IOL implantation in our hospital; (3) agreed to participate and cooperate with this study.
Key exclusion criteria (1 listed)
- acute eye disease symptoms, such as eye redness, eye pain, increased ocular secretions, etc.; (2) other eye diseases that seriously affect visual function in both eyes, such as amblyopia, high myopia, glaucoma, diabetic retinopathy, severe age-related macular degeneration and retinal detachment, etc.; (3) intra-operative or post-operative complications in cataract surgery; combined with other ophthalmic surgeries; and any other ophthalmic surgery for both eyes in the follow-up period; the presence of any other ophthalmic surgery in both eyes in the follow-up period. (4) 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 implention | Procedure or surgery | Orthokeratology group, hyperopia group, myopia group |
Primary outcome
pupil size
Time frame: 1 week, 1 month, 3 months
pupil size before and after cataract 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
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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.
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.