Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma

Open-angle Glaucoma Clinical Trial

Official title:

Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma Compared to Classic Glaucoma Surgeries (Trabeculectomy and Sclerectomy) as Well as Other Minilally Invasive Glaucoma Surgery (MIGS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03904381
• Other study ID #: STM.C240.17.037
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 1, 2016
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2022
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of primary open angle glaucoma
• trabecular meshwork visible in gonioscopy
• medicated IOP of = 15 mmHg and = 35 mmHg
• taking 1 to 5 IOP-lowering medications
• area of healthy, free and mobile conjunctiva in the target quadrant (superior-nasal)
• signed inform consent

Exclusion Criteria:

• angle closure glaucoma
• secondary open angle glaucoma
• previous glaucoma shunt/valve in the target quadrant
• presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
• active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
• active iris neovascularization or neovascularization of the iris within 6 months of the surgical date
• anterior chamber intraocular lens
• presence of intraocular silicone oil
• vitreous present in the anterior chamber
• impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
• known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde)
• history of dermatologic keloid formation
• previous photorefractive keratectomy

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open-angle Glaucoma

Intervention

Drug:
• 5-fluorouracil
5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.

Procedure:
• Transconjunctival needling
Transconjunctival needling was administered according to predetermined criteria.
• Transconjunctival revision
Transconjunctival revision was administered according to predetermined criteria.

Locations

Country	Name	City	State
Poland	Department of Ophthalmology	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Wroclaw Medical University	Wroclaw University of Science and Technology

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Budenz DL, Rhee P, Feuer WJ, McSoley J, Johnson CA, Anderson DR. Comparison of glaucomatous visual field defects using standard full threshold and Swedish interactive threshold algorithms. Arch Ophthalmol. 2002 Sep;120(9):1136-41. — View Citation

Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174/1874364100903020059. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glaucoma Progression	Glaucoma progression was evaluated with the Hodapp-Parrish-Anderson Glaucoma Grading Scale (GGS).; Staging according to the standards given in bibliography (Budenz et all in 2002)	5 years
Other	Change in thickness of the retinal nerve fiber layer (RNFL)	Difference in thickness of the retinal nerve fiber layer during the observation time frame.	5 years
Other	Change in thickness of ganglion cell complex (GCC)	Difference in thickness of ganglion cell complex during the observation time frame.	5 years
Other	Short term changes in IOP after surgery	Evaluated with the use of water drinking test.	5 years
Other	Refractive error	Change in refractive error after glaucoma procedures	5 years
Other	Best-corrected visual acuity	Evaluated on the fixed charts by trained optometrist	5 years
Other	Visual field (VF)	Detection of the visual field abnormalities on the standard machine and during screening procedures	5 years
Other	Disc damage likelihood scale (DDLS)	Evaluation disc damage likelihood scale based on the fundus photographs	5 years
Other	Peripapillar and macular vessels density	Measured on the custom-derived protocol and manufacturer software macular and peripapillar vessels density - Angio OCT (OCTA)	5 years
Primary	Unqualified success	Unqualified success of glaucoma treatment, defined as a postoperative IOP <18 mmHg and >20% reduction compared with the baseline value, achieved without use of any antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.	5 years
Secondary	Qualified success score A	Qualified success of glaucoma treatment, defined as a postoperative IOP <21 mmHg and >20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.	5 years
Secondary	Qualified success score B	Qualified success of glaucoma treatment, defined as a postoperative IOP < 18 mmHg and >20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.	5 years
Secondary	Qualified success score C	Qualified success of glaucoma treatment, defined as a postoperative IOP =15 mmHg and >40% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.	5 years