Diabetic Retinopathy Patients After VitrectomyPPVNCT03485586
Comparison of the Visual Quality of Traditional Ultrasound Biometrics and Lenstar on the Cataract After Pars Plana Vitrectomy
An observational study of Diabetic Retinopathy Patients After Vitrectomy, run by Bojie Hu at 1 site in China.
Trial summary
Comparison of the visual quality of traditional ultrasound biometrics and lenstar on the cataract patients with diabetic retinopathy after vitrectomy in the 3 months later.To evaluate the clinical value of lenstar in post-vitrectomy patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy Patients After Vitrectomy
- What is being tested?
- Traditional ultrasound biometrics and Lenstar
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2018to 31 Oct 2018
- 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: Patients with cataract after vitrectomy because of diabetic retinopathy.
Who may be able to join
- Patients with cataract after vitrectomy because of diabetic retinopathy.
- Patients with good fixation in order to cooperate with various examination.
Who cannot join
- Myopia of >6 diopters
- Ocular trauma and other eye disease accepted vitrectomy,such as branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO).
- Vision acuity <0.1
- Silicone oil eye
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality
bojie HU, docter, 13612130943, hbj151617@163.com
yanhua He, master, 13920555905, heyanhua0104@163.com
About this study
Comparison of the visual quality of traditional ultrasound biometrics and lenstar on the cataract patients with diabetic retinopathy after vitrectomy in the 3 months later.To evaluate the clinical value of lenstar in post-vitrectomy patients.
- Being tested
- Traditional ultrasound biometrics, Lenstar
- Keywords
- cataract, higher order aberration,vitrectomy,diabetic retinopathy
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ultrasound biometricsDevice
To evaluate the clinical feasibility of using a new optical coherence interferometry ( lenstar ),comparing with traditional ultrasonic biometry and keratometry in the accuracy and characteristics for intraocular lens calculation of cataract after PPV
LenstarDevice
To evaluate the clinical feasibility of using a new optical coherence interferometry ( lenstar ),comparing with traditional ultrasonic biometry and keratometry in the accuracy and characteristics for intraocular lens calculation of cataract after PPV
| Study group | Role | What they receive |
|---|---|---|
| Group:Traditional ultrasonic biological | The measurement of axial length was performed in 60 eyes (30 eyes for each group) with senile cataract of vitrectomised eye of diabetic retinopathy using lenstar and traditional ultrasonic biological combined with cornea curvimeter.In this group,we use traditional ultrasonic biological combined with cornea curvimeter to measure the ocular parameter. Receives: Device: Traditional ultrasound biometrics | |
| Group:Lenstar | The measurement of axial length was performed in 60 eyes (30 eyes for each group) with senile cataract of vitrectomised eye of diabetic retinopathy using lenstar and traditional ultrasonic biological combined with cornea curvimeter.In this group,we use lenstar to measure the ocular parameter. Receives: Device: Lenstar |
What is being measured
The primary outcome is the main question the study is designed to answer.
the visual quality of the eye after surgery
the visual quality of the eye after surgery through optical path difference scan（OPD Scan）
Measured: one month
the visual quality of the eye after surgery
the visual quality of the eye after surgery through optical path difference scan（OPD Scan）
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start3 Apr 2018 (estimated)
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy Patients After VitrectomyStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bojie Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bojie Hu, Tianjin Medical University Eye Hospital
- Investigators
- bojie Hu, docter, Study director, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485586
- Sponsor's protocol ID
- HBJ 161718
- Acronym
- PPV
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2018
- Last updated
- 3 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Visual Quality of Traditional Ultrasound Biometrics and Lenstar on the Cataract After Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT03485586
- Acronym / sponsor ID
- PPV / HBJ 161718
- Keywords
- cataract, higher order aberration,vitrectomy,diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bojie HuUniversity, hospital or other
- Study start
- 3 Apr 2018 (estimated)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 2 Apr 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.
Comparison of the visual quality of traditional ultrasound biometrics and lenstar on the cataract patients with diabetic retinopathy after vitrectomy in the 3 months later.To evaluate the clinical value of lenstar in post-vitrectomy patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group:Traditional ultrasonic biological | – | Device: Traditional ultrasound biometricsThe measurement of axial length was performed in 60 eyes (30 eyes for each group) with senile cataract of vitrectomised eye of diabetic retinopathy using lenstar and traditional ultrasonic biological combined with cornea curvimeter.In this group,we use traditional ultrasonic biological combined with cornea curvimeter to measure the ocular parameter. |
| Group:Lenstar | – | Device: LenstarThe measurement of axial length was performed in 60 eyes (30 eyes for each group) with senile cataract of vitrectomised eye of diabetic retinopathy using lenstar and traditional ultrasonic biological combined with cornea curvimeter.In this group,we use lenstar to measure the ocular parameter. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cataract after vitrectomy because of diabetic retinopathy.
Key inclusion criteria (2 listed)
- Patients with cataract after vitrectomy because of diabetic retinopathy.
- Patients with good fixation in order to cooperate with various examination.
Key exclusion criteria (4 listed)
- Myopia of >6 diopters
- Ocular trauma and other eye disease accepted vitrectomy,such as branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO).
- Vision acuity <0.1
- Silicone oil eye
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 |
|---|---|---|
| Traditional ultrasound biometricsTo evaluate the clinical feasibility of using a new optical coherence interferometry ( lenstar ),comparing with traditional ultrasonic biometry and keratometry in the accuracy and characteristics for intraocular lens calculation of cataract after PPV | Device | Group:Traditional ultrasonic biological |
| LenstarTo evaluate the clinical feasibility of using a new optical coherence interferometry ( lenstar ),comparing with traditional ultrasonic biometry and keratometry in the accuracy and characteristics for intraocular lens calculation of cataract after PPV | Device | Group:Lenstar |
Primary outcome
the visual quality of the eye after surgery
Time frame: one month
the visual quality of the eye after surgery through optical path difference scan（OPD Scan）
the visual quality of the eye after surgery
Time frame: three month
the visual quality of the eye after surgery through optical path difference scan（OPD Scan）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: Undecided
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.
bojie Hu, docter study director
Tianjin Medical University Eye 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 Diabetic Retinopathy Patients After Vitrectomy, run by Bojie Hu 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 2 inclusion and 4 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 3 Apr 2018. 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?
Contact bojie Hu, docter (13612130943, hbj151617@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the visual quality of the eye after surgery (time frame: one month). The study lists 2 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 3 Apr 2018.