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Completed

NCT Number: NCT01882413

A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal

This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brandon, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled to undergo cataract removal surgery

Exclusion criteria

  • Current use of eye drops or oral medications for allergic conjunctivitis
  • Serious ocular injury, intraocular surgery, or refractive surgery within 6 months in the study eye
  • Use of a contact lens within 4 weeks

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye

    Time frame: Up to 60 Days Prior to Surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.

Secondary outcomes

  1. Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9

    Time frame: Up to 60 days prior to cataract surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Suspected of having dry eye was defined as a response of "Yes" to the Investigator Dry Eye History question.

  2. Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention

    Time frame: Up to 60 days prior to cataract surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis.

  3. Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining

    Time frame: Up to 60 days prior to cataract surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.

  4. Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs

    Time frame: Up to 60 days prior to cataract surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds.

  5. Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms

    Time frame: Up to 60 days prior to cataract surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.

  6. Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms

    Time frame: Up to 60 days prior to cataract surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.

  7. Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears

    Time frame: Up to 60 Days Prior to Surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Artificial Tear usage was assessed by the investigator.

  8. Percentage of Participants With Elevated MMP-9 With Punctal Plugs

    Time frame: Up to 60 Days Prior to Surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. A history of punctual plug usage was assessed by the investigator.

  9. Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2

    Time frame: Up to 60 Days Prior to Surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.

  10. Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32

    Time frame: Up to 60 Days Prior to Surgery

    Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Acronym: REVEAL

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2013
Registry last updated
Dec 3, 2015

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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