Open-angle Glaucoma
Conditions
Brief summary
To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.
Interventions
DRUG5-fluorouracil
5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.
PROCEDURETransconjunctival needling
Transconjunctival needling was administered according to predetermined criteria.
PROCEDURETransconjunctival revision
Transconjunctival revision was administered according to predetermined criteria.
Sponsors
Wrocław University of Science and Technology
Wroclaw Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unqualified success | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualified success score A | 5 years | 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. |
| Qualified success score B | 5 years | 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. |
| Qualified success score C | 5 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Refractive error | 5 years | Change in refractive error after glaucoma procedures |
| Best-corrected visual acuity | 5 years | Evaluated on the fixed charts by trained optometrist |
| Glaucoma Progression | 5 years | 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) |
| Disc damage likelihood scale (DDLS) | 5 years | Evaluation disc damage likelihood scale based on the fundus photographs |
| Peripapillar and macular vessels density | 5 years | Measured on the custom-derived protocol and manufacturer software macular and peripapillar vessels density - Angio OCT (OCTA) |
| Visual field (VF) | 5 years | Detection of the visual field abnormalities on the standard machine and during screening procedures |
| Change in thickness of the retinal nerve fiber layer (RNFL) | 5 years | Difference in thickness of the retinal nerve fiber layer during the observation time frame. |
| Change in thickness of ganglion cell complex (GCC) | 5 years | Difference in thickness of ganglion cell complex during the observation time frame. |
| Short term changes in IOP after surgery | 5 years | Evaluated with the use of water drinking test. |
Countries
Poland
Outcome results
None listed