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CompletedNCT00411827Updated Sep 20, 2024

Goblet Cell Response and Dry Eye Symptoms After PRK and LASIK

An interventional study of PRK with conjunctival impression cytology before and after surgery and LASIK with conjunctival impression cytology before and after surgery in Keratoconjunctivitis Sicca, sponsored by Walter Reed National Military Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by Walter Reed National Military Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
21 Years to 40 Years
Sex
All
01

Study summary

Purpose: To develop a screening metric by examining both the characteristics of the preoperative tear film and the intracellular signaling pathways of conjunctival goblet cells in order to determine if there are certain characteristics which might predict those patients who will experience serious dry eye symptoms and complications after refractive surgery.

Research Design: This study is a twelve-month prospective non-randomized investigation.

Methodology: In conjunction with psychometric questionnaires and various measures of tear film quality (e.g. Schirmer's test, tear break up time, etc), impression cytology will be used to assess the intracellular signaling pathways of conjunctival goblet cells and to determine if alterations in this pathway exist. Alterations in this pathway would result in a reduced response by the mucin secreting conjunctival goblet cells thereby promoting the development of dry eye after refractive surgery.

02

Conditions studied

  • Keratoconjunctivitis Sicca

Keywords

  • Cytology
  • Keratomileusis, Laser In Situ
  • Keratectomy, Photorefractive, Excimer Laser
03

In context

Keratoconjunctivitis Sicca

85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.

This study's planned enrollment of 146 is above the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.

Browse Keratoconjunctivitis Sicca studies →

Lead sponsor

Walter Reed National Military Medical Center is the lead sponsor of 78 studies on the registry; 20 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects will be recruited from those active duty soldiers that have requested refractive surgery. Subjects must be eligible for medical care at WRAMC.

  1. Male or female, of any race, and at least 21 years old and not older than 40 years old at the time of the pre-operative examination, and have signed an . The lower age limit of 21 years is intended to ensure documentation of refractive stability and is the minimal age required by the FDA for informed consent for LASIK surgery.
  2. Manifest refractive spherical equivalent (MSE) of up to 10.00 diopters at the spectacle plane with refractive cylinder up to 3.00 D.
  3. Best spectacle corrected visual acuity of 20/20 or better in both eyes.
  4. Patients who are willing to fill out dry eye questionnaires.
  5. Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12- month period immediately preceding the baseline examination, as confirmed by clinical records.
  6. All patients must be willing to return to the WRAMC Center for Refractive Surgery for follow up visits on Day1, Day 3, Day 7, and 1, 3, 6, and 12 months after their surgery.
  7. Located in the greater Washington DC area for a 14-month period.
  8. Consent of the subject's command (active duty) to participate in the study.
  9. Access to transportation to meet follow-up requirements.

Exclusion criteria

Exclusion Criteria:

  1. Previous surgery or trauma to the study eye.
  2. Dry eye as reflected by Schirmer's test with anesthesia of 0, subjective complaints or symptoms of dry eye, findings during the slit lamp exam that would be consistent with dry eye (e.g. superficial punctuate keratitis).
  3. Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. This is a standard of care exclusion for refractive surgery at the Walter Reed Refractive Surgery Center because of the medications that are routinely given as part of the procedures. Standard of care analgesia consists of medications (e.g. narcotics) labeled as Pregnancy Category "C" by the FDA. Teratogenic effects are not known, however, physical dependence in the neonate may occur if the mother is given narcotics. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy.
  4. Concurrent topical or systemic medications that may impair healing, including , antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatriptan (Imitrex).
  5. Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
  6. Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or lens opacity.
  7. Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
  8. Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
  9. History of recurrent erosions or epithelial basement dystrophy.
  10. Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
  11. Any physical or mental impairment that would preclude participation in any of the examinations.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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Autoimmune disease

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Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
146 participants (estimated)

Study arms

  • Active comparator
    1

    PRK

    Procedure: PRK with conjunctival impression cytology before and after surgery

  • Active comparator
    2

    LASIK

    Procedure: LASIK with conjunctival impression cytology before and after surgery

Interventions

  • ProcedurePRK with conjunctival impression cytology before and after surgery
  • ProcedureLASIK with conjunctival impression cytology before and after surgery

    LASIK with conjunctival impression cytology before and after surgery

06

What researchers measure

Primary outcomes

  1. Dry eye

    Time frame: one year after surgery

07

Study locations

1 site
  • Walter Reed Army Medical Center
    Washington, District of Columbia 20307, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00411827
Lead sponsor
Walter Reed National Military Medical Center
Collaborators
Schepens Eye Research Institute, State University of New York College of Optometry
Responsible party
Samantha B. Rodgers (Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir, Fort Belvoir Community Hospital) — Principal investigator
First posted
Dec 15, 2006
Start date
Jan 2008
Primary completion
Feb 2011
Completion
May 2016
Last update
Sep 20, 2024

Study contacts

Richard D Stutzman, MD
principal investigator · WRNMMC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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