Evaluation of Filtering Bleb After Glaucoma Surgery by AS-OCTA

Trabeculectomy Clinical Trial

— AS-OCTA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04515017
• Other study ID #: 2020KYPJ119
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: August 2020
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Yiqing Li
• Phone: 13302235127
• Email: liyiqing[@]gzzoc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Those who are over 18 years old and can complete all the tests and examinations.

2. Patients who want to undergo trabeculectomy in accordance with the diagnosis of glaucoma.

3. Intraocular pressure can not be controlled by intraocular pressure lowering drugs and laser therapy (intraocular pressure can not be controlled = 21mmHg).

Exclusion Criteria:

1. Those with a history of ocular trauma, trabeculectomy within 6 months, eye surgery or eye laser within 3 years.

2. The conjunctival state of the proposed surgical area can not support high-quality imaging (signal intensity < 6).

3. Postoperative conjunctival hemorrhage or serious complications, including hyphema, malignant glaucoma, endophthalmitis and so on.

4. The condition of the whole body does not support surgery, such as heart disease, mental illness, malignant tumor, etc.

5. After trabeculectomy, glaucoma drug treatment or reoperation was performed.

6. 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.

Related Conditions & MeSH terms

• Glaucoma
• Trabeculectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

References & Publications (2)

Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Slit lamp microscope	Changes of baseline slit lamp microscope 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.
Secondary	Anterior segment photography	Photographic changes of anterior segment 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.
Secondary	Intraocular pressure	Changes of intraocular pressure 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.
Secondary	Anterior chamber gonioscope	Changes of anterior chamber gonioscope 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.
Secondary	UBM	UBM changes 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.
Secondary	fundus color photography	Changes of fundus color photography 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.
Secondary	A ultrasound	Changes of A-ultrasound at baseline and at different times	The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Secondary	B ultrasound	Changes of B-ultrasound at baseline and at different times	The examination was performed before operation and 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks after operation.
Secondary	visual field	Changes of visual field 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.

External Links

•   Estimated retinal ganglion cell counts for assessing a wide range of glaucoma stages, from preperimetric to advanced
•   Primary open-angle glaucoma