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OpenTrials
Completed

NCT Number: NCT05023304

In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery.
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion criteria

  • Patients under the age of 18.
  • Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test).
  • Active infectious ocular or systemic disease.
  • Patients with active infectious ocular or extraocular disease.
  • Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
  • Patients with known hypersensitivity to Dexamethasone.
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
  • Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C > 10.0.
  • Patients with a history of ocular inflammation or macular edema.
  • Patients with a pre-existing epiretinal membrane (ERM)
  • Patients with allergy or inability to receive intracameral antibiotic.
  • Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL
  • Patients with a corticosteroid implant (i.e. Ozurdex).

Treatment and study plan

Dextenza 0.4Mg Ophthalmic Insert

Drug

The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.

Topical prednisolone acetate

Drug

Standard of care topical drop regimen with four week taper

Primary outcomes

  1. Mean Anterior Chamber Cell/Flare Score

    Time frame: Post-op Day 1

    Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ >50.

  2. Mean Anterior Chamber Cell/Flare Score

    Time frame: Post-op Day 7

    Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ >50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome.

  3. Number of Eyes With No Cell or Flare Measured

    Time frame: post-op Week 4.

    Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ >50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome.

  4. Mean Pain Score

    Time frame: Post-op Day 1

    Mean pain score measured by Visual Analog Score numerical grading scale 0(minimum)-10(maximum) 0= absence of pain 10 = highest possible pain A higher number indicates a higher pain value which may impact a subject's outcomes.

  5. Patient Tolerability (Defined as Patient Preference)

    Time frame: Post-op Week 4

    As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire. The COMTOL questionnaire is designed to assess the tolerability of topical ophthalmic medications. It consists of several elements that help evaluate the frequency, severity, and impact of common side effects: Section 1: Ocular Side Effects; Section 2: Local Side Effects; Section 3: Visual Function; Section 4: Impact on Quality of Life. Likert scale is used to measure each question. 1=Never, 2=Rarely, 3=Sometimes, 4 = Often, 5= Always. A higher score suggests that the medication is less well-tolerated and may be negatively impacting the patient's daily activities and overall well-being.

Secondary outcomes

  1. Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline

    Time frame: postop Day 1

    Intraocular pressure as measured by Goldmann Applanation Tonometer; Total number of Participants with Increased IOP >10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome.

  2. Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline

    Time frame: Postop Day 7

    Intraocular pressure as measured by Goldmann Applanation Tonometer; Total number of Participants with Increased IOP >10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome.

  3. Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline

    Time frame: postop Week 4

    Intraocular Pressure as measured by Goldmann Applanation Tonometer, Total number of Participants with increased IOP > 10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome.

  4. Number of Participants With Post-operative Cystoid Macular Edema (CME)

    Time frame: post-op Week 4

    Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT); Total number of study participants with post-operative CME.

  5. Physician Ease of Use

    Time frame: Day 0

    Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit on Scale of 0-10 with 10 being most complex (0= minimum value or not complex and 10= maximum complexity). A higher number indicates a worse outcome.

  6. Eye Drop Burden Reported by Participants

    Time frame: Post-op Day 7

    Eye Drop Burden Questionnaire numerical grading scale 8 questions on scale of 1-5 totaling a maximum score of 40.

    Likert scale used: 1 Very easy, 2. Easy 3. Neither easy nor difficult 4. Difficult 5. Very difficult Low Burden=8-18 Moderate Burden=19-29 High Burden= 30-40 A higher number score indicates a negative outcome for a subject.

  7. Eye Drop Burden Reported by Participants

    Time frame: post-op Week 4. Patients were not asked to differentiate between eyes when answering the eye drop burden questionnaire

    Eye Drop Burden Questionnaire numerical grading scale 8 questions on scale of 1-5 totaling a maximum score of 40.

    Likert scale used: 1 Very easy, 2. Easy 3. Neither easy nor difficult 4. Difficult 5. Very difficult Low Burden=8-18 Moderate Burden=19-29 High Burden= 30-40 A higher score is considered a worse outcome for a subject.

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Collaborators

  • Ocular Therapeutix, Inc.

Registry information

Acronym: Prepare

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2021
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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