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Eye gel surgery for correction of the retinal hole and retinal membrane with or without cataract removal

Vitrectomy with or without phacoemulsification for treatment of Macular Hole and Epiretinal membrane

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3wmd9s
Enrollment
Unknown
Registered
2018-08-31
Start date
2015-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macula and posterior pole degenerations

Interventions

A prospective study, with 80 patients with BM or MER who did not present significant cataract, will be randomized to half be part of the simultaneous FACO-VPP (phacoemulsification and vitrectomy in th
Procedure/surgery
H33.3

Sponsors

Hospital das Clínicas de Ribeirão Preto
Lead Sponsor
Hospital das Clínicas de Ribeirão Preto
Collaborator

Eligibility

Age
20 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients with a diagnosis of idiopathic macular hole;epiretinal membrane with indication of vitrectomy surgery;Patients without cataract or with opacification of crystalline at most 2 + / 6 + cortical and 2 + / 6 + nuclear, without SCP opacity

Exclusion criteria

Exclusion criteria: another eye disease;Any previous ocular surgery, with the exception of intravitreal injections;Systemic disorders affecting the eye;Inability to report satisfactorily or inability to collaborate, preventing us from obtaining well-documented examinations; Crystalline opacity that interferes with the visualization of the vitreous chamber, that is, posterior subcapsular of any intensity and nuclear or cortical greater or equal to 3+.

Design outcomes

Primary

MeasureTime frame
Improvement in visual acuity in the value of 0.24 logMAR by the ETDRS table. The minimum difference to be detected between the groups of 0.15 logMAR by the ETDRS table, considering power = 80% and with a significance level of 5%.

Secondary

MeasureTime frame
Equivalence in relation to the percentage of surgical success at BM closure and reduction of central macular thickness in MER evaluated by OCT Spectralis (anatomical success), higher incidence of surgical complications between the sequential surgery group compared to the simultaneous surgery group, similarity of the mean threshold Of macular sensitivity to the microperimetry, equivalence in relation to corneal endothelial cell loss, greater difficulty in relation to the feasibility of surgical maneuvers in the sequential group

Countries

Brazil

Contacts

Public Contactrodrigo jorge

Hospital das Clínicas de Ribeirão Preto

rjorge@fmrp.usp.br55-16-36022523

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 26, 2026