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Pain Management in Corneal Collagen Crosslinking for Keratoconus

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ClinicalTrials.gov Identifier: NCT02867176
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary:
This is a prospective, randomized, single blind study. Patients enrolled in the study were randomly assigned to a ketorolac or a gabapentin group for pain control. Different pain scores and variables will be evaluated, along with others side effects variables.

Condition or disease Intervention/treatment Phase
Pain Drug: Gabapentin Drug: Ketorolac Phase 4

Detailed Description:
This is a prospective, randomized, single blind study. Patients enrolled in the study were randomly assigned to the ketorolac or gabapentin group. The gabapentin (Neurontin, Pfizer, Mexico) group was instructed to take one 300-mg capsule the night before surgery and 1 capsule every 8 hours on the day of surgery and for the first 3 postoperative days. The ketorolac group (Dolac, Siegfried Rhein, Mexico) was instructed to take their 10-mg tablets every 8 hours on the day of surgery and for the first 3 postoperative days. Different pain scores and variables will be evaluated, along with others side effects variables.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pain Management in Corneal Collagen Crosslinking for Keratoconus: Prospective Randomized Study
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Corneal collagen CXL epi-off
For the epithelium-off procedure, the corneal epithelium is removed with a 10-minute soak time with isotonic riboflavin 0.1% solution and 4 minutes of exposure with 30 mw/cm2 ultraviolet-A irradiation.
Drug: Gabapentin
The gabapentin (Neurontin, Pfizer, Mexico) group was instructed to take one 300-mg capsule the night before surgery and 1 capsule every 8 hours on the day of surgery and for the first 3 postoperative days.
Other Name: Neurontin

Drug: Ketorolac
The ketorolac group (Dolac, Siegfried Rhein, Mexico) was instructed to take their 10-mg tablets every 8 hours on the day of surgery and for the first 3 postoperative days.
Other Name: Dolac

Corneal collagen CXL epi-on
For the epithelium-on procedure, riboflavin is applied for a total soak of 4 minutes; the cornea is then completely rinsed with additional riboflavin for a total of 6 minutes. The ultraviolet-A irradiation is performed for 2 minutes and 40 seconds at 45mw/cm2.
Drug: Gabapentin
The gabapentin (Neurontin, Pfizer, Mexico) group was instructed to take one 300-mg capsule the night before surgery and 1 capsule every 8 hours on the day of surgery and for the first 3 postoperative days.
Other Name: Neurontin

Drug: Ketorolac
The ketorolac group (Dolac, Siegfried Rhein, Mexico) was instructed to take their 10-mg tablets every 8 hours on the day of surgery and for the first 3 postoperative days.
Other Name: Dolac




Primary Outcome Measures :
  1. Numeric scale of pain [ Time Frame: 5 days ]
    Using a numeric scale of pain, patients were asked to state their pain intensity on a scale of 0 to 10, explaining the patient that a 0 represents no pain at all and a 10 would be the worst pain imaginable.


Secondary Outcome Measures :
  1. Side effects [ Time Frame: 5 days ]
    The last four issues on the questionnaire were related to side effects associated with the use of the medication, specifically dizziness, drowsiness, headaches, and gastrointestinal symptoms

  2. Symptoms related to pain [ Time Frame: 5 days ]
    Patients were asked to rate the severity of four different symptoms during the 24-hour period prior to follow-up: tearing, light sensitivity, foreign body sensation, and discomfort/irritation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with keratoconus older than 18 years with documented bilateral keratometric progression in the previous 6 to 12 months.

Exclusion Criteria:

  • Previous ocular or systemic diseases that could affect epithelial healing; use of topical or systemic non-steroidal anti-inflammatory drugs, or chronic use of any other pain medication, pregnancy and allergy to the drugs of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867176


Sponsors and Collaborators
Instituto de Oftalmología Fundación Conde de Valenciana
Investigators
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Study Chair: Enrique Graue-Hernandez, Md, MSc Instituto de Oftalmologia Conde de Valenciana

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Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana
ClinicalTrials.gov Identifier: NCT02867176     History of Changes
Other Study ID Numbers: CXL-PAIN
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases
Ketorolac
Ketorolac Tromethamine
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors