Pain Management in Corneal Collagen Crosslinking for Keratoconus

NCT02867176 | Completed Phase 4

• 1 other identifier: CXL-PAIN
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Numeric scale of pain

  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.

  5 days

Secondary Outcomes (2)

• Side effects

  5 days

• Symptoms related to pain

  5 days

Study Arms (2)

Corneal collagen CXL epi-off

OTHER

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; Drug: Ketorolac

Corneal collagen CXL epi-on

OTHER

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; Drug: Ketorolac

Interventions

Gabapentin DRUG

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.

Also known as: Neurontin

Corneal collagen CXL epi-off; Corneal collagen CXL epi-on

Ketorolac DRUG

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.

Also known as: Dolac

Corneal collagen CXL epi-off; Corneal collagen CXL epi-on

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

MeSH Terms

Conditions

Pain

Interventions

Gabapentin; Ketorolac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Enrique Graue-Hernandez, Md, MSc

  Instituto de Oftalmologia Conde de Valenciana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 15, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 15, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share