Optical Coherence TomographyNCT04499768
A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy
An observational study of Optical Coherence Tomography and Diabetic Retinopathy, run by Ruijin Hospital at 1 site in China.
Trial summary
To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Optical Coherence Tomography, Diabetic Retinopathy, Choroid
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Dec 2020
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: 23 eyes of 23 cataract patients with mild/moderate NPDR without DME, and 23 age-matched non-diabetic patients
Who may be able to join
- aged⩾40years; intraocular pressure (IOP) < 21 mm Hg in both eyes, spherical refractive error<6 diopters spherical equivalent.
Who cannot join
- previous retinal surgery, glaucoma, uveitis, age-related macular degeneration, arterial or vein occlusions, macular hole, or other ocular diseases that could interfere the CT and/or CVI measurement, severe systemic diseases, such as uncontrolled hypertension, obstructive sleep apnea, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal Study of Choroidal Changes Assessed With Swept-source Optical Coherence Tomography After Cataract Surgery in Eyes With Diabetic Retinopathy
To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery
Read the detailed description
To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence tomography (SS-OCT) system.
- Conditions
- Optical Coherence Tomography, Diabetic Retinopathy, Choroid
- Keywords
- Diabetic choroidopathy, Diabetic retinopathy, choroidal vascularity index, choroidal thickness
- Medical subject headings
- Diabetic Retinopathy
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 |
|---|---|---|
| control | the age-related cataract patients | |
| DR group | the cataract patients with mild/moderate NPDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVI at baseline
choroidal vascularity index(CVI) was defined as the proportion of vascular area to total circumscribed area.
Measured: CVI was assessed at baseline(within 1 week before surgery)
CVI at 1 week postoperatively
choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.
Measured: CVI was assessed 1 week after surgery.
CVI at 1 month postoperatively
choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.
Measured: CVI was assessed 1 month after surgery.
CVI at 3 months postoperatively
choroidal vascularity index (CVI)was defined as the proportion of vascular area to total circumscribed area.
Measured: CVI was assessed 3 months after surgery.
CT at baseline
Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
Measured: CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.
CT at 1 week postoperatively
Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
Measured: CT was assessed at 1 week after surgery.
CT at 1 month postoperatively
Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
Measured: CT was assessed at 1 month after surgery.
CT at 3 months postoperatively
Choroid thickness (CT) was the thickness of the choroidal layer, CT values were obtained with the built-in software of the SS-OCT device.
Measured: CT was assessed at 3 months after surgery.
VD at baseline
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
Measured: VD of the choriocapillaris was assessed at baseline.
VD at 1 week postoperatively
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
Measured: VD of the choriocapillaris was assessed 1 week after surgery.
VD at 1 month postoperatively
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
Measured: VD of the choriocapillaris was assessed 1 month after surgery.
VD at 3 months postoperatively
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid
Measured: VD of the choriocapillaris was assessed 3 months after surgery.
Secondary outcomes (6)
IOP at baseline
IOP was the value of intraocular pressure.
Measured: IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.
IOP at 1 week postoperatively
IOP was the value of intraocular pressure .
Measured: IOP was assessed 1 week after surgery.
IOP at 1 month postoperatively
IOP was the value of intraocular pressure.
Measured: IOP was assessed 1 month after surgery.
IOP at 3 months postoperatively
IOP was the value of intraocular pressure .
Measured: IOP was assessed 3 months after surgery.
BCVA at baseline
BCVA was the best corrected visual acuity.
Measured: BCVA was assessed at baseline .
BCVA at 3 months postoperatively
BCVA was the best corrected visual acuity.
Measured: BCVA was assessed 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jun 2018
- Primary completion30 Oct 2019
- Study completion30 Dec 2020 (estimated)
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 Optical Coherence TomographyStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Shen, Ruijin Hospital
- Investigators
- Xi Shen, PhD, Study director, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499768
- Sponsor's protocol ID
- 2018ZY14
- Status last verified
- Aug 2020
- First submitted
- 30 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yao H, Gao S, Liu X, Zhou Y, Cheng Y, Shen X. Choroidal Structural Changes Assessed with Swept-Source Optical Coherence Tomography after Cataract Surgery in Eyes with Diabetic Retinopathy. J Ophthalmol. 2020 Oct 29;2020:5839837. doi: 10.1155/2020/5839837. eCollection 2020.
PubMed 33178452
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Choroidal Changes Assessed With Swept-source Optical Coherence Tomography After Cataract Surgery in Eyes With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04499768
- Acronym / sponsor ID
- 2018ZY14
- Conditions
- Optical Coherence Tomography, Diabetic Retinopathy, Choroid
- Keywords
- Diabetic choroidopathy, Diabetic retinopathy, choroidal vascularity index, choroidal thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 5 Aug 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 determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery
Detailed description
To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence tomography (SS-OCT) system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –the age-related cataract patients |
| DR group | – | –the cataract patients with mild/moderate NPDR |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 23 eyes of 23 cataract patients with mild/moderate NPDR without DME, and 23 age-matched non-diabetic patients
Key inclusion criteria (1 listed)
- aged⩾40years; intraocular pressure (IOP) < 21 mm Hg in both eyes, spherical refractive error<6 diopters spherical equivalent.
Key exclusion criteria (1 listed)
- previous retinal surgery, glaucoma, uveitis, age-related macular degeneration, arterial or vein occlusions, macular hole, or other ocular diseases that could interfere the CT and/or CVI measurement, severe systemic diseases, such as uncontrolled hypertension, obstructive sleep apnea, etc.
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
CVI at baseline
Time frame: CVI was assessed at baseline(within 1 week before surgery)
choroidal vascularity index(CVI) was defined as the proportion of vascular area to total circumscribed area.
CVI at 1 week postoperatively
Time frame: CVI was assessed 1 week after surgery.
choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.
CVI at 1 month postoperatively
Time frame: CVI was assessed 1 month after surgery.
choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.
CVI at 3 months postoperatively
Time frame: CVI was assessed 3 months after surgery.
choroidal vascularity index (CVI)was defined as the proportion of vascular area to total circumscribed area.
CT at baseline
Time frame: CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.
Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
CT at 1 week postoperatively
Time frame: CT was assessed at 1 week after surgery.
Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
CT at 1 month postoperatively
Time frame: CT was assessed at 1 month after surgery.
Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.
CT at 3 months postoperatively
Time frame: CT was assessed at 3 months after surgery.
Choroid thickness (CT) was the thickness of the choroidal layer, CT values were obtained with the built-in software of the SS-OCT device.
VD at baseline
Time frame: VD of the choriocapillaris was assessed at baseline.
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
VD at 1 week postoperatively
Time frame: VD of the choriocapillaris was assessed 1 week after surgery.
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
VD at 1 month postoperatively
Time frame: VD of the choriocapillaris was assessed 1 month after surgery.
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.
VD at 3 months postoperatively
Time frame: VD of the choriocapillaris was assessed 3 months after surgery.
VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid
6 secondary outcomes
IOP at baseline
Time frame: IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.
IOP at 1 week postoperatively
Time frame: IOP was assessed 1 week after surgery.
IOP at 1 month postoperatively
Time frame: IOP was assessed 1 month after surgery.
IOP at 3 months postoperatively
Time frame: IOP was assessed 3 months after surgery.
BCVA at baseline
Time frame: BCVA was assessed at baseline .
BCVA at 3 months postoperatively
Time frame: BCVA was assessed 3 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Derived from this study: PubMed 33178452Yao H, Gao S, Liu X, Zhou Y, Cheng Y, Shen X. Choroidal Structural Changes Assessed with Swept-Source Optical Coherence Tomography after Cataract Surgery in Eyes with Diabetic Retinopathy. J Ophthalmol. 2020 Oct 29;2020:5839837. doi: 10.1155/2020/5839837. eCollection 2020.
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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.
Xi Shen, PhD study director
Shanghai Jiao Tong University School of Medicine
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 Optical Coherence Tomography and Diabetic Retinopathy, run by Ruijin 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 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 5 Aug 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?
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?
CVI at baseline (time frame: CVI was assessed at baseline(within 1 week before surgery)). The study lists 12 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 NCT04499768, 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 5 Aug 2020.