Evaluation of Filtering Bleb After Glaucoma Surgery by AS-OCTA

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04515017

Collaborator

(none)

Enrollment

11.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trabeculectomy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Study on the Value and Mechanism of AS-OCTA in the Evaluation of Filtering Bleb Function and Outcome After Glaucoma Surgery

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Aug 30, 2021

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Vision [The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.]
Changes of visual acuity at baseline and at different time points
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.]
Changes of baseline slit lamp microscope at different time points
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.]
Photographic changes of anterior segment at baseline and at different time points
Intraocular pressure [The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.]
Changes of intraocular pressure at baseline and at different time points
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.]
Changes of anterior chamber gonioscope at baseline and at different time points
UBM [The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.]
UBM changes at baseline and at different time points
fundus color photography [The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.]
Changes of fundus color photography at baseline and at different time points
A ultrasound [The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.]
Changes of A-ultrasound at baseline and at different times
B ultrasound [The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.]
Changes of B-ultrasound at baseline and at different times
visual field [The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.]
Changes of visual field at baseline and at different time points

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.