Macula pucker Epiretinal membrane Epiretinaal membraaan vision loss visus daling
Conditions
Interventions
Randomized patients 2:1 for robotic assistance vs standard surgery will undergo a vitreoretinal procedure to remove an epiretinal membrane. At various steps of the surgery, the step will be either car
Sponsors
Preceyes, Eindhoven, the Netherlands
Oogziekenhuis Rotterdam, Rotterdam, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Epiretinal membrane requiring surgery and confirmed on Spectral OCT scans BCVA (best corrected visual acuity) < 0.5 Age ¡Ý 18 years Written informed consent obtained from the patient prior to inclusion in the study OR if patient cannot read, written informed consent has been provided by an impartial witness after written or verbal assent from the patient.
Exclusion criteria
Exclusion criteria: Presence of scleral ectasia in the area of trocar placement. Prior surgery involving the sclera in the zone of trocar placement. Prior surgery in the previous 3 months. Myopia > 6 D. Insufficient transparency of ocular media (e.g. lens opacity, vitreous haemorrhage) if this will not be removed at the time of surgery Corneal decompensation or expected decompensation as a result of cataract surgery Use of anticoagulants. Patient unable to follow verbal instructions regarding positioning. Patient unable to remain quiet and still for the duration of surgery. Any patient that the surgeon feels is unfit to undergo surgery within this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall - degree of nerve fiber layer changes at 3 months post surgery in an OCT macular cube. For individual surgical step: presence/absence of surgical trauma, retinal hemorrhage; response of the surgeon to a standard questionnaire post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction based on a questionnaire. Similar evaluation on concerns by the operating room personnel. Time required for each surgical step and overall time involved in conducting surgery | — |
Outcome results
None listed