Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
- Conditions
- Vitreoretinal Disease
- Registration Number
- NCT02477605
- Lead Sponsor
- Alcon Research
- Brief 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.
- Detailed Description
Required follow-up for this study is 3 months post treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean Change in Intraocular Pressure (IOP) on Operative Day Day 0 preoperative, Day 0 postoperative IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.
- Secondary Outcome Measures
Name Time Method Mean Post-operative Pain Rating at Day 1 Day 1 post operative The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable.
Mean Conjunctival Edema Score at Week 1 Week 1 post operative Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis.
Related Research Topics
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Trial Locations
- Locations (1)
Contact Alcon Call Center for Trial Locations
🇺🇸Fort Worth, Texas, United States
Contact Alcon Call Center for Trial Locations🇺🇸Fort Worth, Texas, United States