N/A N=136 Randomized Single-blind Treatment

Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes

Vitreoretinal Disease

Bottom Line

View on ClinicalTrials.gov: NCT02477605 ↗

Enrolled (actual)

136

Serious AEs

7.9%

Results posted

Jul 2017

Primary outcome: Primary: Mean Change in Intraocular Pressure (IOP) on Operative Day — -0.40; -3.05 mmHG

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CONSTELLATION® 27-gauge Combined Surgical Pak (Device); CONSTELLATION® 23-gauge Combined Surgical Pak (Device); Vitrectomy surgery (Procedure)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Jun 2016

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.