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NCT Number: NCT04342988

Effect of Cequa Treatment on Accuracy of Pre-operative Biometry & Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery

The purpose of this study is to examine the effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Harvard Eye Associates, Laguna Hills, California, United States

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About this study

Hypothesis: In patients with dry eye, defined as corneal staining and a reduced tear breakup time, the accuracy of pre-operative biometry and corneal surface HOAs will improve significantly after four weeks of Cequa treatment.

Primary Outcome Measure: Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.

Secondary Outcome Measures:

The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.

The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.

The difference in corneal staining and tear breakup time (TBUT) before and after treatment with Cequa.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with planned cataract surgery,
  • The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale
  • Reduced tear break up time (TBUT) ≤ 10 seconds.
  • Able to comprehend and sign a statement of informed consent.
  • Willing and able to complete all required postoperative visits.

Exclusion criteria

  • Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
  • Clinically significant ocular trauma.
  • Active ocular Herpes simplex or Herpes Zoster infection
  • Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
  • Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
  • Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
  • Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
  • Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
  • Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
  • Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
  • Participation in this trial in the same patient's fellow eye
  • Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.

Treatment and study plan

Cequa

Drug

The effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.

Primary outcomes

  1. Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.

    Time frame: Four weeks

Secondary outcomes

  1. The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.

    Time frame: Four Weeks

  2. The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.

    Time frame: Four Weeks

    To compare the difference in Standard Patient of Eye Dryness Questionnaire (SPEED) scores before and after 4 weeks of therapy with Cequa BID among patients with significant dry eye (decreased TBUT or corneal staining) with planned cataract surgery. The SPEED questionnaire gives a score from 0-28 that is the result of 8 items that assess frequency and severity of symptoms. Speed Score Severity rating: 0-4 Mild, 5-7 Moderate, 8+ Severe.

  3. The difference in corneal staining before and after treatment with Cequa.

    Time frame: Four Weeks

    The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale.

  4. The difference in tear breakup time (TBUT) before and after treatment with Cequa.

    Time frame: Four Weeks

    Reduced tear break up time (TBUT) ≤ 10 seconds.

Sponsors and collaborators

Lead sponsor

Research Insight LLC

Industry

Registry information

Official study title

Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Mar 12, 2021

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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