The PRIME Study: A Randomized, Controlled, Prospective Study

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age22-75
SponsorVance Thompson Vision - MT

About this trial

To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better

Willing and able to comply with clinic visits and study related procedures

Willing and able to sign the informed consent form

Disqualifiers

Patients under the age of 22 or above the age of 75

Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).

Patients with active infectious ocular or extraocular disease.

Patients actively treated with local or systemic immunosuppression including systemic corticosteriods

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dextenza

    Drug

    Dextenza 0.4mg

  • Topical Prednisolone

    Drug

    Standard of care topical drop treatment

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Group A DextenzaActive comparator 1 intervention
Group B: Group B Topical PrednisoloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient Preference

As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)

Time frame
Through Month 1

Secondary outcomes

1

Percentage of eyes that have CME (Cystoid macular edema) post-operatively

Measured by OCT (Optical Coherence Tomography )

Time frame
Through Month 1
2

Mean pain score per eye (Group A vs Group B)

Measured by Visual Analog Scale (0-10, 10 being the worst outcome)

Time frame
Through Month 1
3

Incidence of post-operative corneal haze

measured by OCT (Optical Coherence Tomography)

Time frame
Through Month 1
4

Grade of post-operative corneal haze

measured by OCT (Optical Coherence Tomography)

Time frame
Through Month 1

Other outcomes

Sponsors and contacts

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