Glaucoma
Conditions
Interventions
Trabectome, 75 eyes of 75 subjects
ab interno trabeculotomy using microhook, 75 eyes of 75 subjects
Sponsors
Kobe University Hospital, Department of Ophthalmology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Open anterior chamber angle with Shaffer classification grade III or IV 2) Ocular hypertension, primary open angle glaucoma, exfoliation syndrome, or exfoliation glaucoma 3) At screening, IOP is reproducibly equal to or more than 20 and less than 40 mmHg under at least 1 anti-glaucoma medication use 4) No history of intraocular surgery other than cataract surgery 5) Mean deviation better than -12dB, and two or less juxtafoveal points with 0 dB on the Humphrey visual field 30-2 or 24-2 program or equivalent 6) A patient who voluntarily provides us a written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) A patient with only one functional eye 2) Inapplicability to Goldmann applanation tonometry 3) Presence or a history of uveitis 4) A patient who received oral, topical, or subTenon injection of corticosteroid within 6 months 5)Presence or a history of diabetes 6) A pacemaker recipient 7) A patient who received cataract surgery on the nominated eye withn 6 months 8) A history of laser trabeculoplasty or laser iridotomy 9) Corneal endothelial density less than 1000/mm2 10) A pregnant or breast-feeding woman, or a woman who plans to be pregnant 11) An individual who participated in other studies within 4 months 12) A patient judged to be ineligible for any reason by a doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of treatment success. Definition: Surgery is defined as success if any "event" described blow does not happen at 1 month after surgery. Then, the duration of treatment success is defined as a duration from the operation day to a time when any one of the 4 events happens in the eye with surgey success. Event: 1)At two consecutive visits, IOP exceeds 21mmHg or does not reach 5mmHg. 2)IOP reduction rate compared with baseline does not reach 20%. 3)Glaucoma medical therapy is augmented. 4)Additional glaucoma surgery is required. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Outcome 1) Duration of treatment success defined by more stringent criteria. Thus, event 1)is defined as that at two consecutive visits, IOP exceeds 18mmHg or does not reach 5mmHg. Other 3 events are the same as those used in the primary outcome meausure. 2)Pre- and postoperative IOP at 1, 3, 6 and 12 months. 3)The number of Pre- and postoperative anti-glaucoma medications. 4)Success or failure of surgery at 12 months. 5)Presence or absence of additional glaucoma surgery. Safety Outcomes 1) Presence, amount, and duration of hyphema 2)Presence, amount, and duration of transient postoperative IOP spike. 3)Corneal endothelial density at 12 months after surgery. 4) Other adverse events. Other Outcomes (Expolatory Outcomes) 1) Presence and degree of peripheral anterior synechie. 2) Final IOP | — |
Countries
Japan
Contacts
Public ContactYuko Yamada
Kobe University Hospital Ophthalmology
Outcome results
None listed