NCT02477605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

July 16, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 27, 2017

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 18, 2015

Results QC Date

May 30, 2017

Last Update Submit

May 31, 2018

Conditions

Vitreoretinal Disease

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Intraocular Pressure (IOP) on Operative Day

    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.

    Day 0 preoperative, Day 0 postoperative

Secondary Outcomes (2)

  • Mean Conjunctival Edema Score at Week 1

    Week 1 post operative

  • Mean Post-operative Pain Rating at Day 1

    Day 1 post operative

Study Arms (2)

27-gauge pak

EXPERIMENTAL

CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery

Device: CONSTELLATION® 27-gauge Combined Surgical PakProcedure: Vitrectomy surgery

23-gauge pak

ACTIVE COMPARATOR

CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery

Device: CONSTELLATION® 23-gauge Combined Surgical PakProcedure: Vitrectomy surgery

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.

27-gauge pak
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.

23-gauge pak
Vitrectomy surgeryPROCEDURE

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

23-gauge pak27-gauge pak

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to provide informed consent and attend all required study visits;
  • Requires vitrectomy in at least one eye;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

Results Point of Contact

Title
Brand Lead, Global Medical Affairs
Organization
Alcon, A Novartis Division
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Clinical Manager, Surgical, GCRA

    Alcon, A Novartis Division

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 23, 2015

Study Start

July 16, 2015

Primary Completion

June 1, 2016

Study Completion

August 31, 2016

Last Updated

July 2, 2018

Results First Posted

July 27, 2017

Record last verified: 2017-06

Locations

US(1)