Vitreoretinal DiseaseNCT02477605

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

A study testing CONSTELLATION® 27-gauge Combined Surgical Pak, CONSTELLATION® 23-gauge Combined Surgical Pak and Vitrectomy surgery in people with Vitreoretinal Disease, run by Alcon Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Vitreoretinal Disease
What is being tested?: CONSTELLATION® 27-gauge Combined Surgical Pak, CONSTELLATION® 23-gauge Combined Surgical Pak and Vitrectomy surgery
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 1 siteUnited States
Study dates: 16 Jul 2015to 31 Aug 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Read the detailed description

Required follow-up for this study is 3 months post treatment.

Conditions: Vitreoretinal Disease
Being tested: CONSTELLATION® 27-gauge Combined Surgical Pak, CONSTELLATION® 23-gauge Combined Surgical Pak, Vitrectomy surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02477605
Study group	Role	What they receive
27-gauge pak	Experimental	CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery Receives: Device: CONSTELLATION® 27-gauge Combined Surgical Pak; Procedure: Vitrectomy surgery
23-gauge pak	Active comparator	CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery Receives: Device: CONSTELLATION® 23-gauge Combined Surgical Pak; Procedure: Vitrectomy surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 0 preoperative, Day 0 postoperative

Secondary outcomes (2)

Mean Conjunctival Edema Score at Week 1
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.
Measured: Week 1 post operative
Mean Post-operative Pain Rating at Day 1
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.
Measured: Day 1 post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 201531 Aug 2016

First posted23 Jun 2015 (estimated)
Study start16 Jul 2015
Primary completion1 Jun 2016
Study completion31 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vitreoretinal DiseaseStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02477605
Sponsor's protocol ID: VRH172-P001
Status last verified: Jun 2017
First submitted: 18 Jun 2015
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
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All Vitreoretinal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
ClinicalTrials.gov ID: NCT02477605
Acronym / sponsor ID: VRH172-P001
Conditions: Vitreoretinal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 16 Jul 2015 (actual)
Primary completion: 1 Jun 2016 (actual)
Study completion: 31 Aug 2016 (actual)
First posted: 23 Jun 2015 (estimated)
Results: Posted 27 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Required follow-up for this study is 3 months post treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
27-gauge pak	Experimental	Device: CONSTELLATION® 27-gauge Combined Surgical Pak, Procedure: Vitrectomy surgeryCONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
23-gauge pak	Active comparator	Device: CONSTELLATION® 23-gauge Combined Surgical Pak, Procedure: Vitrectomy surgeryCONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CONSTELLATION® 27-gauge Combined Surgical PakSterile 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.	Device	27-gauge pak
CONSTELLATION® 23-gauge Combined Surgical PakSterile 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.	Device	23-gauge pak
Vitrectomy surgeryMicroincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases	Procedure or surgery	23-gauge pak, 27-gauge pak

Primary outcome

Mean Change in Intraocular Pressure (IOP) on Operative Day
Time frame: 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.

2 secondary outcomes

Mean Conjunctival Edema Score at Week 1
Time frame: Week 1 post operative
Mean Post-operative Pain Rating at Day 1
Time frame: Day 1 post operative

Results and safety

Results posted to the registry on 27 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
27-Gauge	68	67
23-Gauge	68	64

Primary outcome: Mean Change in Intraocular Pressure (IOP) on Operative Day

Time frame: Day 0 preoperative, Day 0 postoperative. Mean (Standard Deviation). Unit: mmHG

Measure	27-Gauge n = 67	23-Gauge n = 68
Value	-0.40 (6.603)	-3.05 (7.639)

Population analysed: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
27-Gauge Treated Eye	15 of 66 (22.7%)	18 of 66 (27.3%)	0 of 66
27-Gauge Fellow Eye	0 of 66 (0%)	0 of 66 (0%)	0 of 66
27-Gauge Systemic	0 of 66 (0%)	0 of 66 (0%)	0 of 66
23-Gauge Treated Eye	16 of 69 (23.2%)	14 of 69 (20.3%)	0 of 69
23-Gauge Fellow Eye	0 of 69 (0%)	0 of 69 (0%)	0 of 69
23-Gauge Systemic	1 of 69 (1.4%)	0 of 69 (0%)	0 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Vitreoretinal Disease

RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Active, not recruiting
Ocular Hypotony and Refractive Predictability in RRD Surgery
Rhegmatogenous Retinal Detachment, Hypotony Ocular
Not yet recruitingObservational study
OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
Retinal Detachment, Macular Edema
Recruiting
Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
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Recruiting
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Manager, Surgical, GCRA study director

Alcon, A Novartis Division

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Intraocular Pressure (IOP) on Operative Day (time frame: Day 0 preoperative, Day 0 postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02477605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.