Evaluation of Filtering Bleb After Glaucoma Surgery by AS-OCTA
AS-OCTA
Study on the Value and Mechanism of AS-OCTA in the Evaluation of Filtering Bleb Function and Outcome After Glaucoma Surgery
1 other identifier
observational
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2020
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 17, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedAugust 17, 2020
August 1, 2020
12 months
August 5, 2020
August 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (10)
Vision
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
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Anterior segment photography
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Intraocular pressure
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Anterior chamber gonioscope
The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
- +5 more secondary outcomes
Eligibility Criteria
Patients preparing for trabeculectomy for glaucoma
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. doi: 10.1016/S0140-6736(04)16257-0.
PMID: 15158634BACKGROUNDYamazaki 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.
PMID: 27741375BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2020
First Posted
August 17, 2020
Study Start
September 1, 2020
Primary Completion
August 30, 2021
Study Completion
August 30, 2021
Last Updated
August 17, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share