CataractNCT05716269
Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients
An observational study of Cataract and Hyperopia, run by Peking University Third Hospital.
Trial summary
To evaluate visual outcomes and patient satisfactory after PanOptix implantation in hyperopic cataract patients Read more about this study
- Who is it for?
- Ages 45 to 80 years
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Dec 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hyperopic cataract patients receiving bilateral uneventful phacoemulsification and implantation of PanOptix.
Who may be able to join
- age-related cataract patients
- Eye axis length ≤22.5mm and refraction ≥ +0.5D
- Predicted postoperative corneal astigmatism ≤0.75D
- mesopic pupil size between 3.0mm to 5.5 mm
- Preoperative angle kappa ≤ 0.5 mm
- Preoperative corneal spherical aberration <0.5μm, high order aberration <0.5μm
Who cannot join
- In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
- Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis
- Patients with history of ocular trauma or prior ocular surgery including refractive procedures
- Preoperative visual acuity of worse than 0.2 logMAR in any eye.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients: a Prospective, Cohort Study
To evaluate visual outcomes and patient satisfactory after PanOptix implantation in hyperopic cataract patients
Read the detailed description
Patients with axial length ≤22.5mm will be recruited. The subjects will undergo bilateral uneventful phacoemulsification and implantation of PanOptix. Visual quality and patients satisfactory will be assessed three months after the surgery.
- Medical subject headings
- Cataract, Hyperopia
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected distance visual acuity of the operated eye
Best corrected distance visual acuity (BCDVA) of the operated eye will be measured.
Measured: 3 months postoperatively
Secondary outcomes (7)
Uncorrected distance visual acuity (UCVA)
Uncorrected distance visual acuity (UCVA) of the operated eye will be measured at 5m.
Measured: 3 months postoperatively
Uncorrected intermediate visual acuity
Uncorrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.
Measured: 3 months postoperatively
Uncorrected near visual acuity
Uncorrected near visual acuity of the operated eye will be measured at 40cm.
Measured: 3 months postoperatively
Best corrected intermediate visual acuity
Best corrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.
Measured: 3 months postoperatively
Best corrected near visual acuity
Best corrected near visual acuity of the operated eye will be measured at 40cm.
Measured: 3 months postoperatively
Manifest refraction spherical equivalent
Manifest refraction spherical equivalent of the operated eye will be measured
Measured: 3 months postoperatively
Visual disturbance, spectacle independence and patient satisfaction
A questionnaire including visual disturbance, spectacle independence and patient satisfaction will be distributed to subjects.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Eye Hospital
- Responsible party
- Principal investigator, Hong Qi, Peking University Third Hospital
- Investigators
- Hong Qi, MD, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716269
- Sponsor's protocol ID
- 2022756
- Status last verified
- Feb 2023
- First submitted
- 22 Jan 2023
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients: a Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT05716269
- Acronym / sponsor ID
- 2022756
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Tianjin Eye Hospital
- Study start
- Feb 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Feb 2023 (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 visual outcomes and patient satisfactory after PanOptix implantation in hyperopic cataract patients
Detailed description
Patients with axial length ≤22.5mm will be recruited. The subjects will undergo bilateral uneventful phacoemulsification and implantation of PanOptix. Visual quality and patients satisfactory will be assessed three months after the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hyperopic cataract patients receiving bilateral uneventful phacoemulsification and implantation of PanOptix.
Key inclusion criteria (6 listed)
- age-related cataract patients
Key exclusion criteria (5 listed)
- In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
- Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis
- Patients with history of ocular trauma or prior ocular surgery including refractive procedures
- Preoperative visual acuity of worse than 0.2 logMAR in any eye.
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
Best corrected distance visual acuity of the operated eye
Time frame: 3 months postoperatively
Best corrected distance visual acuity (BCDVA) of the operated eye will be measured.
7 secondary outcomes
Uncorrected distance visual acuity (UCVA)
Time frame: 3 months postoperatively
Uncorrected intermediate visual acuity
Time frame: 3 months postoperatively
Uncorrected near visual acuity
Time frame: 3 months postoperatively
Best corrected intermediate visual acuity
Time frame: 3 months postoperatively
Best corrected near visual acuity
Time frame: 3 months postoperatively
Manifest refraction spherical equivalent
Time frame: 3 months postoperatively
Visual disturbance, spectacle independence and patient satisfaction
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
Hong Qi, MD, PhD principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Hyperopia, run by Peking University Third Hospital.
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 6 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Contact Hong Qi, MD, PhD (13901066889, doctorqihong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected distance visual acuity of the operated eye (time frame: 3 months postoperatively). 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 8 Feb 2023.