CataractPhase 4PrepareNCT05023304
In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Topical prednisolone acetate in people with Cataract, run by Vance Thompson Vision at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert and Topical prednisolone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 1 Oct 2022
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
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.
- Conditions
- Cataract
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert, Topical prednisolone acetate
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza 0.4Mg Ophthalmic InsertDrug
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 acetateDrug
Standard of care topical drop regimen with four week taper
| Study group | Role | What they receive |
|---|---|---|
| Group A Dextenza | Experimental | Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery. Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
| Group B Topical Prednisolone | Active comparator | Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery. Receives: Drug: Topical prednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Anterior Chamber Cell/Flare Score
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.
Measured: Post-op Day 1
Mean Anterior Chamber Cell/Flare Score
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.
Measured: Post-op Day 7
Number of Eyes With No Cell or Flare Measured
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.
Measured: post-op Week 4.
Mean Pain Score
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.
Measured: Post-op Day 1
Patient Tolerability (Defined as Patient Preference)
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.
Measured: Post-op Week 4
Secondary outcomes (7)
Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline
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.
Measured: postop Day 1
Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline
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.
Measured: Postop Day 7
Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline
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.
Measured: postop Week 4
Number of Participants With Post-operative Cystoid Macular Edema (CME)
Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT); Total number of study participants with post-operative CME.
Measured: post-op Week 4
Physician Ease of Use
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.
Measured: Day 0
Eye Drop Burden Reported by Participants
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.
Measured: Post-op Day 7
Eye Drop Burden Reported by Participants
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.
Measured: post-op Week 4. Patients were not asked to differentiate between eyes when answering the eye drop burden questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start23 Aug 2021
- Primary completion27 Jul 2022
- Study completion1 Oct 2022
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 CataractStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor
- Investigators
- Mitch Ibach, OD, Principal investigator, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023304
- Sponsor's protocol ID
- The Prepare Study
- Acronym
- Prepare
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2021
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
- ClinicalTrials.gov ID
- NCT05023304
- Acronym / sponsor ID
- Prepare / The Prepare Study
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Dextenza | Experimental | Drug: Dextenza 0.4Mg Ophthalmic InsertRandomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery. |
| Group B Topical Prednisolone | Active comparator | Drug: Topical prednisolone acetateRandomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Dextenza 0.4Mg Ophthalmic InsertThe 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. | Drug | Group A Dextenza |
| Topical prednisolone acetateStandard of care topical drop regimen with four week taper | Drug | Group B Topical Prednisolone |
Primary outcome
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.
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.
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.
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.
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.
7 secondary outcomes
Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline
Time frame: postop Day 1
Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline
Time frame: Postop Day 7
Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline
Time frame: postop Week 4
Number of Participants With Post-operative Cystoid Macular Edema (CME)
Time frame: post-op Week 4
Physician Ease of Use
Time frame: Day 0
Eye Drop Burden Reported by Participants
Time frame: Post-op Day 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mitch Ibach, OD principal investigator
Vance Thompson Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Topical prednisolone acetate in people with Cataract, run by Vance Thompson Vision at 1 site in United States.
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 13 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 17 Aug 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2025). 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 Anterior Chamber Cell/Flare Score (time frame: Post-op Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2025.