At a glance

ClinicalIndex Comparison Record

N/ACompleted· 137 enrolled

Drug / intervention

CONSTELLATION® 27-gauge Combined Surgical Pak +2 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02477605

NCT02477605N/ACompleted

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

Alcon Research·interventional·Posted Jun 23, 2015·Updated Jul 2, 2018

In Brief

A clinical study evaluating CONSTELLATION® 27-gauge Combined Surgical Pak, CONSTELLATION® 23-gauge Combined Surgical Pak, and 1 other intervention for Vitreoretinal Disease. Completed, enrolled 137 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsVitreoretinal Disease

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

20162017201820192020202120222023202420252026

First PostedJun 2015

Enrollment StartJul 2015

Primary CompletionJun 2016

Study CompletionAug 2016

TodayJul 2026

First PostedJun 23, 2015

Enrollment StartJul 16, 2015

Primary CompletionJun 1, 2016

Study CompletionAug 31, 2016

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 11.0 years ago

Interventions

CONSTELLATION® 27-gauge Combined Surgical Pakdevice

Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 27-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 27-gauge EDGEPLUS® Valved Entry System comprised of 3 trocar/cannulas and related accessories.

CONSTELLATION® 23-gauge Combined Surgical Pakdevice

Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 23-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 23-gauge EDGEPLUS® trocar/cannula set comprising of 3 trocars/cannulas and related accessories.

Vitrectomy surgeryprocedure

Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases