Evaluation of Filtering Bleb After Glaucoma Surgery by AS... | NCT04515017

Studies
Evaluation of Filtering Bleb After Glaucoma Surgery by AS-OCTA

NCT04515017

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Status

Unknown status

Last Update Posted

Aug 17, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Trabeculectomy

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Aug 30, 2021Estimated

Completion Date

Aug 30, 2021Estimated

First Submitted Date

Aug 5, 2020

First Submission Date that Met QC Criteria

Aug 12, 2020

First Posted Date

Aug 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2020

Last Update Posted Date

Aug 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

When antihypertensive drugs or laser therapy can not reach the target intraocular pressure, trabeculectomy (TRAB) is still the standard surgical method for glaucoma. The scarring of the operative area is a common reason for the failure of trabeculectomy. After trabeculectomy, maintaining the shape and function of the filtering bleb is an important aspect to maintain the surgical effect. The increase in the number of blood vessels on the filtering bleb and the morphological curvature are often the manifestations of decompensation of the filtering bleb. Angiogenesis in the filtering bleb region plays an important role in surgical incision healing and is related to the accompanying scar formation. Therefore, the evaluation of vascular distribution of filtering blebs is an important index and early parameter to evaluate the success or failure of surgery. With the improvement of detection methods, it is possible to use AS-OCTA to evaluate the function and prognosis of filtering bleb after trabeculectomy. Antimitotic drugs such as 5-fluorouracil (5-FU) or mitomycin C (MMC) have always been the most commonly used clinical drugs, but the side effects caused by their use are not satisfactory. It is still the research direction of glaucoma to find new targets for regulating wound healing and more safe and effective drugs.

Detailed Description

Glaucoma is a group of optic nerve diseases characterized by progressive and irreversible degeneration of retinal ganglion cells and their axons. Retinal ganglion cells, RGCs is a kind of central nervous system neuron whose cell bodies are located in the retina and axons make up the optic nerve. When antihypertensive drugs or laser therapy can not reach the target intraocular pressure, trabeculectomy (TRAB) is still the standard surgical method for glaucoma. The scarring of the operative area is a common reason for the failure of trabeculectomy. After trabeculectomy, maintaining the shape and function of the filtering bleb is an important aspect to maintain the surgical effect. The increase in the number of blood vessels on the filtering bleb and the morphological curvature are often the manifestations of decompensation of the filtering bleb. Angiogenesis in the filtering bleb region plays an important role in surgical incision healing and is related to the accompanying scar formation. Therefore, the evaluation of vascular distribution of filtering blebs is an important index and early parameter to evaluate the success or failure of surgery. With the improvement of detection methods, it is possible to use AS-OCTA to evaluate the function and prognosis of filtering bleb after trabeculectomy. Antimitotic drugs such as 5-fluorouracil (5-FU) or mitomycin C (MMC) have always been the most commonly used clinical drugs, but the side effects caused by their use are not satisfactory. It is still the research direction of glaucoma to find new targets for regulating wound healing and more safe and effective drugs.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in the results of baseline AS-OCTA at different points in time	AS-OCTA	AS-OCTA was performed before operation, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.

Secondary Outcomes

Measure	Description	Time Frame
Vision	Changes of visual acuity at baseline and at different time points	The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Slit lamp microscope

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those who are over 18 years old and can complete all the tests and examinations.
Patients who want to undergo trabeculectomy in accordance with the diagnosis of glaucoma.
Intraocular pressure can not be controlled by intraocular pressure lowering drugs and laser therapy (intraocular pressure can not be controlled ≤ 21mmHg).

Exclusion Criteria:

Those with a history of ocular trauma, trabeculectomy within 6 months, eye surgery or eye laser within 3 years.
The conjunctival state of the proposed surgical area can not support high-quality imaging (signal intensity < 6).
Postoperative conjunctival hemorrhage or serious complications, including hyphema, malignant glaucoma, endophthalmitis and so on.
The condition of the whole body does not support surgery, such as heart disease, mental illness, malignant tumor, etc.
After trabeculectomy, glaucoma drug treatment or reoperation was performed.
Pregnant, lactating and pregnant women. Those who refuse to sign the informed consent form or voluntarily withdraw from the study due to discomfort or other reasons.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients preparing for trabeculectomy for glaucoma

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Yiqing Li	Contact	13302235127		liyiqing@gzzoc.com
Man Luo	Contact	15940173740		412375497@qq.com

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15158634	Background	Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. doi: 10.1016/S0140-6736(04)16257-0.
27741375	Background	Yamazaki M, Omodaka K, Takahashi H, Nakazawa T. Estimated retinal ganglion cell counts for assessing a wide range of glaucoma stages, from preperimetric to advanced. Clin Exp Ophthalmol. 2017 Apr;45(3):310-313. doi: 10.1111/ceo.12852. Epub 2016 Nov 13. No abstract available.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases