Pupil DiameterNCT04982107
Quality of Vision in Implantable Collamer Lens (ICL)
An observational study of Pupil Diameter, run by He Eye Hospital at 1 site in China.
Trial summary
The aim of this study is to observe the influence of pupil size upon visual outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pupil Diameter
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Sep 2021
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Randomly choosen patients from the hospital records who had ICL surgery at He Eye Hospital, Shenyang, China during September 2019 to September 2020. They must have signed informed consent for their records to be used for education and research purposes before undergoing ICL surgery for myopic correction.
Who may be able to join
- Myopic eyes
- Preoperative corneal endothelial cell count ≥2200/mm2
- Preoperative central anterior chamber depth> 2.80mm
- Intraocular pressure within the normal range (10-21mmHg)
Who cannot join
- Severe dry eye
- Cataract and glaucoma
- Patients with uveitis
- Retinal detachment
- Patients with autoimmune diseases
- Patients with systemic diseases such as diabetes and hypertension
- Patients with mental or cognitive abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pupil Influence on the Quality of Vision in Implantable Collamer Lens (ICL)
The aim of this study is to observe the influence of pupil size upon visual outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation.
Read the detailed description
The aim of this study is to observe the influence of pupil size upon the quality of vision outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation. Pre-operation and 3-month post-operation pupil size, visual acuity, quality of vision will be evaluated in patient that had ICL surgery.
- Conditions
- Pupil Diameter
- Keywords
- ICL, QoV, Visual acuity
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Quality of vision
Change in QoV questionnaire score after ICL surgery at 3-month testing will be compare with baseline measurements
Measured: Baseline (before surgery) and 3 month after surgery
Pupil diameter pre-operation and post-operation
Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements
Measured: Baseline (before surgery) and 3 month after surgery
Wave front aberrometry
Change in Wave front aberrometry after ICL surgery at 3-month testing will be compare with baseline measurements
Measured: baseline and 3 month after surgery
Point Spread Function (PSF)
Change in Point Spread Function (PSF) after ICL surgery at 3-month testing will be compare with baseline measurements
Measured: baseline and 3 month after surgery
Strehl ratio
Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements
Measured: Baseline and 3 month after surgery
Modulation transfer function (MTF)
Change in Modulation transfer function after ICL surgery at 3-month testing will be compare with baseline measurements
Measured: Baseline and 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pupil DiameterStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei He, Study chair, He Eye Specialist Hospital, Shenyang.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982107
- Sponsor's protocol ID
- ICL2020
- Status last verified
- Jul 2021
- First submitted
- 26 Jan 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupil Influence on the Quality of Vision in Implantable Collamer Lens (ICL)
- ClinicalTrials.gov ID
- NCT04982107
- Acronym / sponsor ID
- ICL2020
- Conditions
- Pupil Diameter
- Keywords
- ICL, QoV, Visual acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 29 Jul 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.
The aim of this study is to observe the influence of pupil size upon visual outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation.
Detailed description
The aim of this study is to observe the influence of pupil size upon the quality of vision outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation. Pre-operation and 3-month post-operation pupil size, visual acuity, quality of vision will be evaluated in patient that had ICL surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Randomly choosen patients from the hospital records who had ICL surgery at He Eye Hospital, Shenyang, China during September 2019 to September 2020. They must have signed informed consent for their records to be used for education and research purposes before undergoing ICL surgery for myopic correction.
Key inclusion criteria (4 listed)
- Myopic eyes
- Preoperative corneal endothelial cell count ≥2200/mm2
- Preoperative central anterior chamber depth> 2.80mm
- Intraocular pressure within the normal range (10-21mmHg)
Key exclusion criteria (7 listed)
- Severe dry eye
- Cataract and glaucoma
- Patients with uveitis
- Retinal detachment
- Patients with autoimmune diseases
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
Subjective Quality of vision
Time frame: Baseline (before surgery) and 3 month after surgery
Change in QoV questionnaire score after ICL surgery at 3-month testing will be compare with baseline measurements
Pupil diameter pre-operation and post-operation
Time frame: Baseline (before surgery) and 3 month after surgery
Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements
Wave front aberrometry
Time frame: baseline and 3 month after surgery
Change in Wave front aberrometry after ICL surgery at 3-month testing will be compare with baseline measurements
Point Spread Function (PSF)
Time frame: baseline and 3 month after surgery
Change in Point Spread Function (PSF) after ICL surgery at 3-month testing will be compare with baseline measurements
Strehl ratio
Time frame: Baseline and 3 month after surgery
Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements
Modulation transfer function (MTF)
Time frame: Baseline and 3 month after surgery
Change in Modulation transfer function after ICL surgery at 3-month testing will be compare with baseline measurements
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 1 Feb 2022.
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.
Wei He study chair
He Eye Specialist Hospital, Shenyang.
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 Pupil Diameter, run by He Eye 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 7 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 1 Feb 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?
Subjective Quality of vision (time frame: Baseline (before surgery) and 3 month after surgery). The study lists 6 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 1 Feb 2022.