N/A
Completed N=136
Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
Vitreoretinal Disease
Source: ClinicalTrials.gov NCT02477605 ↗
Enrolled (actual)
136
Serious AEs
7.9%
Results posted
Jul 2017
Primary outcomePrimary: Mean Change in Intraocular Pressure (IOP) on Operative Day — -0.40; -3.05 mmHG
Summary
The purpose of this study is to compare the treatment day change between immediate postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and 23-gauge vitrectomy instruments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Intraocular Pressure (IOP) on Operative Day |
-0.40; -3.05 | — |
| SECONDARY Mean Conjunctival Edema Score at Week 1 |
0.02; 0.10 | — |
| SECONDARY Mean Post-operative Pain Rating at Day 1 |
0.9; 0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide informed consent and attend all required study visits;
- Requires vitrectomy in at least one eye;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Previous vitrectomy or glaucoma surgery;
- Planned treatment requires scleral buckling, combined procedures (eg, cataract surgery), silicone oil, and expansive gas other than sterile air;
- Treated with topical IOP lowering medication(s) at any time from baseline assessment to time of surgery;
- Pregnant or planning to become pregnant during the course of the trial;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02477605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.