Efficacy of Surgical Systems in Combination With Phacoemulsification: a Retrospective Analysis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBarnet Dulaney Perkins Eye Centers

About this trial

Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with h/o CEIOL/OMNI/Hydrus (chosen based on subjects on more than 1 medication pre-operatively) with at least 3 years of follow up data

have Glaucoma

Disqualifiers

Patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies.

Patients with refractory CME or CME persisting 3 months or more post-operatively

Patients with incomplete IOP, medication logs or VF data within post-operative period

Prior incisional surgery or MIGS

Trial population

300 subjects that have undergone CEIOL/OMNI/Hydrus

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis

    Procedure/Surgery

    The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Single Group/Cohort retrospectively utilized1 intervention

Trial outcomes

Primary outcomes

1

Measured Efficacy of Surgical Process with Phacoemulsification

Primary endpoint stratified by complete or qualified success: • Proportion of patients with complete success (%) - without the use of medications

Time frame
24 months

Secondary outcomes

1

Additional Benefits of the Surgical System and Phacoemulsification

• Proportion of patients with qualified success (%) - with glaucoma meds without increase from baseline

Time frame
36 months
2

Additional Benefits of the Surgical System and Phacoemulsification

• Overall IOP reduction from baseline (mmHg)

Time frame
36 months
3

Additional Benefits of the Surgical System and Phacoemulsification

• Overall medication reduction (#0-5)

Time frame
36 months
4

Additional Benefits of the Surgical System and Phacoemulsification

• Rate of mean deviation change (dB)

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barnet Dulaney Perkins Eye Centers

Lead sponsor

Alcon, a Novartis Company

Collaborator