AdolescentNCT04443231
Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation
An observational study of Adolescent and Adult, run by Peking University Third Hospital at 1 site in China.
Trial summary
To observe the retinal microvascular alteration during 3 months follow-up after Implantable Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical coherence tomography angiography (OCTA) analysis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent, Adult, Human
- What is being tested?
- Optical Coherence Tomography Angiography
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 1 Oct 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Moderate and high myopia patients, underwent ICL implantation surgery at the Department of Ophthalmology, Peking University Third Hospital
Who may be able to join
- 18 to 45 years old;
- Binocular myopia, with a refraction of greater than -3 diopters (D);
- anterior chamber depth (ACD, measured from the endothelium to the crystalline lens) > 2.8 mm;
- corneal endothelial cell count (cECC) ≥ 2000 cells/mm2;
- stable refraction at least 1 year before surgery;
- unsatisfactory vision with contact lenses or spectacles.
Who cannot join
- history of intraocular surgery
- other ocular pathology (uveitis, glaucoma, cataract, keratoconus, severe dry eye, etc.)
- other serious systemic disease (diabetes, uncontrolled hypertension, severe hyperthyroidism, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
To observe the retinal microvascular alteration during 3 months follow-up after Implantable Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical coherence tomography angiography (OCTA) analysis.
Read the detailed description
The study object is moderate and high myopia patients, underwent ICL implantation. OCTA was used to image the superficial and deep retinal vascular plexuses before ICL implantation surgery and at 3 months follow-up. OCTA images were corrected for magnification, skeletonized, separated the large vessels and partitioned. Retinal microvascular density was measured by using fractal dimension analysis. The aim of this study was to uncover potential retinal vascular network alterations induced by ICL implantation surgery.
- Conditions
- Adolescent, Adult, Human, Male, Female, Follow-up Studies
- Being tested
- Optical Coherence Tomography Angiography
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography AngiographyDevice
AngioVue (Optovue, Fremont, CA, USA) was used to capture the OCTA images before ICL surgery and at 3 months follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal microvessels density
Retinal microvessels density was measured with fractal dimension analysis by using Matalb (The Mathworks, Inc., Natick, MA, USA)
Measured: 3 months postoperatively
Secondary outcomes (4)
Best corrected visual acuity
BCVA was evaluated by decimal Snellen and converted to the logarithm of the minimum angle of resolution (logMAR) for statistical analysis.
Measured: 3 months postoperatively
Mean refractive spherical equivalent
MRSE = Spherical power + 0.5 * Cylindrical power
Measured: 3 months postoperatively
Intraocular pressure
The IOP was measured using a non-contact tonometer (CT-80; Topcon, Tokyo, Japan).
Measured: 3 months postoperatively
Vault
The central vault of the ICL (distance from posterior surface of ICL to the crystalline lens) was measured using Optical Coherence Tomography (Visante; Carl Zeiss Meditec, Jena, Germany)
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 posted23 Jun 2020
- Study start1 Nov 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AdolescentStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Qi, PhD, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443231
- Sponsor's protocol ID
- tch0101
- Status last verified
- Jul 2019
- First submitted
- 17 Mar 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004 Sep;111(9):1683-92. doi: 10.1016/j.ophtha.2004.03.026.
PubMed 15350323Yang Y, Wang J, Jiang H, Yang X, Feng L, Hu L, Wang L, Lu F, Shen M. Retinal Microvasculature Alteration in High Myopia. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6020-6030. doi: 10.1167/iovs.16-19542.
PubMed 27820633Li M, Yang Y, Jiang H, Gregori G, Roisman L, Zheng F, Ke B, Qu D, Wang J. Retinal Microvascular Network and Microcirculation Assessments in High Myopia. Am J Ophthalmol. 2017 Feb;174:56-67. doi: 10.1016/j.ajo.2016.10.018. Epub 2016 Nov 4.
PubMed 27818204
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation
- ClinicalTrials.gov ID
- NCT04443231
- Acronym / sponsor ID
- tch0101
- Conditions
- Adolescent, Adult, Human, Male, Female, Follow-up Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 23 Jun 2020 (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 observe the retinal microvascular alteration during 3 months follow-up after Implantable Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical coherence tomography angiography (OCTA) analysis.
Detailed description
The study object is moderate and high myopia patients, underwent ICL implantation. OCTA was used to image the superficial and deep retinal vascular plexuses before ICL implantation surgery and at 3 months follow-up. OCTA images were corrected for magnification, skeletonized, separated the large vessels and partitioned. Retinal microvascular density was measured by using fractal dimension analysis. The aim of this study was to uncover potential retinal vascular network alterations induced by ICL implantation surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Moderate and high myopia patients, underwent ICL implantation surgery at the Department of Ophthalmology, Peking University Third Hospital
Key inclusion criteria (6 listed)
- 18 to 45 years old;
- Binocular myopia, with a refraction of greater than -3 diopters (D);
- anterior chamber depth (ACD, measured from the endothelium to the crystalline lens) > 2.8 mm;
- corneal endothelial cell count (cECC) ≥ 2000 cells/mm2;
- stable refraction at least 1 year before surgery;
Key exclusion criteria (3 listed)
- history of intraocular surgery
- other ocular pathology (uveitis, glaucoma, cataract, keratoconus, severe dry eye, etc.)
- other serious systemic disease (diabetes, uncontrolled hypertension, severe hyperthyroidism, etc.).
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 |
|---|---|---|
| Optical Coherence Tomography AngiographyAngioVue (Optovue, Fremont, CA, USA) was used to capture the OCTA images before ICL surgery and at 3 months follow-up. | Device | – |
Primary outcome
Retinal microvessels density
Time frame: 3 months postoperatively
Retinal microvessels density was measured with fractal dimension analysis by using Matalb (The Mathworks, Inc., Natick, MA, USA)
4 secondary outcomes
Best corrected visual acuity
Time frame: 3 months postoperatively
Mean refractive spherical equivalent
Time frame: 3 months postoperatively
Intraocular pressure
Time frame: 3 months postoperatively
Vault
Time frame: 3 months postoperatively
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 23 Jun 2020.
- Background: PubMed 15350323Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004 Sep;111(9):1683-92. doi: 10.1016/j.ophtha.2004.03.026.
- Results publication: PubMed 27820633Yang Y, Wang J, Jiang H, Yang X, Feng L, Hu L, Wang L, Lu F, Shen M. Retinal Microvasculature Alteration in High Myopia. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6020-6030. doi: 10.1167/iovs.16-19542.
- Results publication: PubMed 27818204Li M, Yang Y, Jiang H, Gregori G, Roisman L, Zheng F, Ke B, Qu D, Wang J. Retinal Microvascular Network and Microcirculation Assessments in High Myopia. Am J Ophthalmol. 2017 Feb;174:56-67. doi: 10.1016/j.ajo.2016.10.018. Epub 2016 Nov 4.
- 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.
Hong Qi, PhD, MD study director
Peking University Third 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 Adolescent and Adult, run by Peking University Third 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 6 inclusion and 3 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 23 Jun 2020. 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?
Retinal microvessels density (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?
On the ClinicalTrials.gov record for NCT04443231, which also lists 3 linked publications.
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 23 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.