Subluxation of LensNCT03752710
Biometry of Occult Lens Subluxation Misdiagnosed as Primary Acute Angle Closed Glaucoma
An observational study of Subluxation of Lens, run by Tianjin Medical University Eye Hospital.
Trial summary
In this work, we evaluated the biometry data of lens subluxation inducing acute angle closure which were misdiagnosed as primary angle closure at the first visit, and compared with the data of chronic angle closure glaucoma, cataract, primary acute angle closure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subluxation of Lens
- How many people
- 183 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective case study included 17 eyes of 17 patients with ASAC-LS, who were misdiagnosed with APACG on their first visit. In addition, 56 eyes of 56 patients diagnosed with APACG, 54 eyes of 54 patients diagnosed with CPACG, and 56 eyes of 56 patients diagnosed with cataract were also included. All of the patients were admitted from Jan 10, 2016 to Dec 28, 2017 in Tianjin Medical University Hospital. This study was conducted in accordance with the Helsinki Declaration and was approved by the Ethics Committee of Tianjin Medical University Eye Hospital.
ASAC-LS was diagnosed according to the following criteria, including sudden pain in the eye, decreased vision with or without nausea and vomiting. Slit lamp microscopy reveals phacodonesis, lens inclination or vitreous herniation into the anterior chamber, central and peripheral shallow anterior chamber, and asymmetric iris bulge. All patients were confirmed during the surgery to have LS.
APACG was diagnosed with the following criteria6, 7 8, including substantially elevated IOP and closed angle, acute eye pain, blurred vision, or nausea and vomiting. More importantly, ischemic injury caused by acute ocular hypertension, ciliary or mixed congestion, corneal edema, and glaucoma flecks should be detected.
The diagnostic criteria of CPACG included narrow angle with anterior synechiae of varying widths, IOP > 22 mmHg, and glaucomatous optic disc damage and visual field shrinkage9-11 The angle closure should be more than two quadrants, yet there was no ischemic injury in the anterior segment caused by acute ocular hypertension.
Exclusion criteria were history of laser peripheral iridotomy or peripheral iridectomy, glaucoma filtration surgery, angle closure caused by ocular trauma, uveitis, neovascularization or lens swelling or hyper mature lens. The patients with acute angle closure in both eyes were excluded. The subjects in which Lenstar LS900 examination could not be performed because of severe lens opacity or corneal edema were also not included in the study.
About this study
Official title: Biometric Indicators of Eyes With Occult Lens Subluxation
In this work, we evaluated the biometry data of lens subluxation inducing acute angle closure which were misdiagnosed as primary angle closure at the first visit, and compared with the data of chronic angle closure glaucoma, cataract, primary acute angle closure.
- Conditions
- Subluxation of Lens
- Medical subject headings
- Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute primary angle closure | Not described | |
| Acute secondary angle closure induced by LS | Not described | |
| Cataract | Not described | |
| Primary chronic angle closed glaucoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye anterior segment biometry
Anterior segment biometry measure by Lenstar LS900
Measured: 1 day
Intraocular pressure
Intraocular pressure was measured by Goldmann tonometer
Measured: 1 year
visual acuity
visual acuity before and after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study startJan 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subluxation of LensStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lv Yingjuan, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752710
- Sponsor's protocol ID
- Tianjin LS study
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xing X, Huang L, Tian F, Zhang Y, Lv Y, Liu W, Liu A. Biometric indicators of eyes with occult lens subluxation inducing secondary acute angle closure. BMC Ophthalmol. 2020 Mar 5;20(1):87. doi: 10.1186/s12886-020-01355-7.
PubMed 32138781
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biometric Indicators of Eyes With Occult Lens Subluxation
- ClinicalTrials.gov ID
- NCT03752710
- Acronym / sponsor ID
- Tianjin LS study
- Conditions
- Subluxation of Lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Nov 2018 (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.
In this work, we evaluated the biometry data of lens subluxation inducing acute angle closure which were misdiagnosed as primary angle closure at the first visit, and compared with the data of chronic angle closure glaucoma, cataract, primary acute angle closure.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute primary angle closure | – | – |
| Acute secondary angle closure induced by LS | – | – |
| Cataract | – | – |
| Primary chronic angle closed glaucoma | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective case study included 17 eyes of 17 patients with ASAC-LS, who were misdiagnosed with APACG on their first visit. In addition, 56 eyes of 56 patients diagnosed with APACG, 54 eyes of 54 patients diagnosed with CPACG, and 56 eyes of 56 patients diagnosed with cataract were also included. All of the patients were admitted from Jan 10, 2016 to Dec 28, 2017 in Tianjin Medical University Hospital. This study was conducted in accordance with the Helsinki Declaration and was approved by the Ethics Committee of Tianjin Medical University Eye Hospital.
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
Eye anterior segment biometry
Time frame: 1 day
Anterior segment biometry measure by Lenstar LS900
Intraocular pressure
Time frame: 1 year
Intraocular pressure was measured by Goldmann tonometer
visual acuity
Time frame: 1 year
visual acuity before and after surgery
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 27 Nov 2018.
- Derived from this study: PubMed 32138781Xing X, Huang L, Tian F, Zhang Y, Lv Y, Liu W, Liu A. Biometric indicators of eyes with occult lens subluxation inducing secondary acute angle closure. BMC Ophthalmol. 2020 Mar 5;20(1):87. doi: 10.1186/s12886-020-01355-7.
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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 Subluxation of Lens, run by Tianjin Medical University Eye Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. 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?
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?
Eye anterior segment biometry (time frame: 1 day). The study lists 3 primary outcomes in all. 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 NCT03752710, which also lists 1 linked publication.
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 27 Nov 2018.