Open Angle Glaucoma
Conditions
Interventions
Group I (GI) will include about 40 patients undergoing one Trabeculectomy.
Group II (GII) will include about 40 patients undergoing one CPC
Procedure/surgery
E02.520.745
Q65.070
Sponsors
Centro de Referência em Oftalmologia da Universidade Federal de Goiás (CEROF-UFG)
Centro de Referência em Oftalmologia da Universidade Federal de Goiás (CEROF-UFG)
Clínica de Oftalmologia de Osasco
Instituto de Olhos Ciências Médicas
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Univisão Clínica Oftalmológica
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: The study will include patients aged over 18 years with the following glaucoma subtypes: POAG, pigmentary glaucoma (PG), pseudo-exfoliation glaucoma (PEX), and cortisone glaucoma. The patients must have glaucoma refractory to clinical treatment and not in the target IOP, defined by the physician responsible for the case or with VF progression (22) confirmed with the current IOP. All patients must have at least one reliable SITA Standard 24-2 VF exam (Humphrey Systems, Dublin, CA, USA) and with characteristic glaucoma changes according to the criteria proposed by Hodapp-Parrish-Anderson (HPA) (23), OD examination showing typical glaucoma lesion, i.e., neural rim focal thinning or global loss, vascular changes, and/or localized RNFL defects (24), and the ability to perform VF testing in at least one eye. Pseudo-phakic patients must have a history of a previous cataract surgery using the phacoemulsification technique (PHACO ) with a corneal incision without stitches and intraocular lens (IOL) implantation within a capsular bag and without complications described in the patient’s medical chart and/or confirmed with detailed examination of the eye in mydriasis.
Exclusion criteria
Exclusion criteria: Exclusion criteria will be as follows: absence of light perception vision; loss or deficit of vision in any eye of unknown cause or other than glaucoma; unreliable VF; aphakia or any other changes at biomicroscopy or ophthalmoscopy that may affect VF examination, such as age-related macular degeneration (AMD) or retinal detachment (RD); or recent participation in another research protocol (six months). VF will only be an inclusion criterion for patients with corrected VA better than 20/200. Patients below this level will not undergo the VF exam to be included in the study. Pregnant or lactating patients will be excluded from the study. Patients with a history of any other intraocular surgery (except cataracts, as previously described); previous anti-glaucoma surgery (any technique); need for other surgeries concomitant with glaucoma surgery, such as for cataracts; aphakia; history of cataracts with complications, such as posterior capsule rupture, vitreous loss, or IOL implantation in the groove; conjunctival scars that may prevent or hinder TREC, such as sequelae from burns or pterygium surgery; corneal scars that may hinder the IOP measurement; or history or evidence of uveitis (active or not) will also be excluded. Patients with ocular hypertension, normal pressure glaucoma (NPG), PCAG, neovascular glaucoma (even treated), congenital or juvenile glaucoma, endothelial iridocorneal syndrome, traumatic glaucoma, secondary glaucoma, or any conditions that, at medical discretion, will contraindicate any of the techniques proposed in the study will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical failure rate between groups, defined as an eye pressure (IOP) greater than 21 mmHg or less than 20% reduction in relation to the baseline in 2 consecutive postoperative visits after 3 months of follow-up, loss of light perception, IOP < 6 mmHg on two consecutive visits after 3 months, need for a new surgical intervention to control IOP, or at medical discretion if the IOP is not within the established target, or with confirmed functional progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the success rate between groups, considered as an IOP ? 6 mmHg and less than 21 mmHg, in addition to a reduction of> 20% in IOP, absence of surgical reinterventions, after 12 months of follow-up with or without maximum tolerated medication, success qualified and complete, respectively, in addition to the absence of serious complications; Evaluate the reduction of hypotensive drugs among these patients, measured as the number of eye drops used before and with up to 12 months of surgical intervention; Assess visual acuity and visual field pre and postoperatively (6 months and 1 year) among these patients; Evaluate quality of life and cost / effectiveness between the two interventions studied in the primary surgical treatment of glaucoma using the EuroQol 5 dimensions questionnaire and the QALY (Quality Adjusted Life Years), in addition to questionnaires with data on family income, days of absence from the number of postoperative visits, procedures performed and number of eye drops bottles used. The questionnaires will be carried out before and 12 months after the operation | — |
Countries
Brazil
Contacts
Public ContactCláudia Franco
Centro de Referência em Oftalmologia da Universidade Federal de Goiás (CEROF-UFG)
Outcome results
None listed