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Riboflavin at 4ºC for the Management of Pain After Crosslinking for Keratoconus Patients

Primary Purpose

Keratoconus, Crosslinking

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
corneal collagen crosslinking
Sponsored by
Instituto de Oftalmología Fundación Conde de Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Crosslinking, Keratoconus, Cold, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients of any gender
  • older than 18 years
  • diagnosis of keratoconus who require management with crosslinking in both eyes for evidence of progression.

Exclusion Criteria:

  • crosslinking without removal of epithelium or unilateral crosslinking.
  • patients with other ocular conditions different from keratoconus.
  • cognitive disability that limits the compression of the pain test as Down syndrome, etc.

Sites / Locations

  • Instituto de oftalmología conde de ValencianaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Riboflavin at 4ºC

Riboflavin at room temperature

Arm Description

patients treated with Riboflavin at 4ºC in crosslinking (cases).

patients treated with Riboflavin at room temperature in crosslinking (controls)

Outcomes

Primary Outcome Measures

Change pain perception in patients undergoing crosslinking with riboflavin at 4ºC
A previously validated numerical pain scale questionnaire was applied. Patients are asked to indicate their pain intensity on a scale of 0 to 10, explaining that 0 does not represent pain at all and 10 is a severe and disabling pain.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2018
Last Updated
November 29, 2018
Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
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1. Study Identification

Unique Protocol Identification Number
NCT03760770
Brief Title
Riboflavin at 4ºC for the Management of Pain After Crosslinking for Keratoconus Patients
Official Title
Riboflavin at 4ºC for the Management of Pain After Crosslinking for Keratoconus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: The objective of corneal collagen crosslinking (CXL) is to increase the binding of intrafibrillary and interfibrillary covalent bonds to improve the mechanical stability of the cornea and thus to stop the progression of corneal ectasias. Although the vast majority of studies have described pain after photorefractive keratectomy (PRK), the pathophysiological principle of pain is similar in CXL. From the anatomical point of view, the corneal epithelium is the most densely innervated and sensitive surface of the body, being 300-600 times greater than in the skin. The pain after CXL comes from several routes, the process begins with the epithelial rupture that generates exposure of the nerve endings, induces apoptosis and necrosis of the epithelial cells. Subsequently an inflammatory cascade is initiated in which the different cytokines stimulate the nerve terminals. Inflammatory mediators also activate the ion channels in the nerve membrane, and this process continues until the epithelium heals. Additionally, exposure to UVA rays can also cause nerve damage. The effect of local cold for pain management has already been reported in PRK. By cooling the cornea, the release of chemical mediators and inflammation can be reduced. In the CXL radiation is transformed into several forms of energy: fluorescent radiation, chemical energy and, to a small extent, heat. The CXL process is energetically comparable to photosynthesis, in which the radiation energy is transformed into chemical energy (glucose) with the help of pigments (chlorophyll). The thermal effect is negligible in the photochemical method of CXL. Justification: No method for the control of pain after crosslinking is considered ideal or universally accepted, the importance of this study lies in looking for an additional tool to reduce the most common postoperative complaint in a highly performed procedure worldwide. Hypothesis: The application of riboflavin at 4oC reduces the pain assessment after the CXL. Purpose: to evaluate the effect of the application of riboflavin at 4oC in the assessment of postoperative pain in patients undergoing CXL. Materials and methods: Prospective and interventional clinical study in patients older than 18 years with a diagnosis of keratoconus who underwent CXL, in the cornea and refractive surgery service of the Ophthalmology institute Fundación Conde de Valenciana.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Crosslinking
Keywords
Crosslinking, Keratoconus, Cold, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Riboflavin at 4ºC
Arm Type
Experimental
Arm Description
patients treated with Riboflavin at 4ºC in crosslinking (cases).
Arm Title
Riboflavin at room temperature
Arm Type
Experimental
Arm Description
patients treated with Riboflavin at room temperature in crosslinking (controls)
Intervention Type
Procedure
Intervention Name(s)
corneal collagen crosslinking
Other Intervention Name(s)
No Cold riboflavin (Riboflavin at room temperature), Cold riboflavin (Riboflavin at 4ºC)
Intervention Description
Crosslinking in patients with progressive keratoconus.
Primary Outcome Measure Information:
Title
Change pain perception in patients undergoing crosslinking with riboflavin at 4ºC
Description
A previously validated numerical pain scale questionnaire was applied. Patients are asked to indicate their pain intensity on a scale of 0 to 10, explaining that 0 does not represent pain at all and 10 is a severe and disabling pain.
Time Frame
2 postoperative hours and from day 1 to 5 postoperative.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients of any gender older than 18 years diagnosis of keratoconus who require management with crosslinking in both eyes for evidence of progression. Exclusion Criteria: crosslinking without removal of epithelium or unilateral crosslinking. patients with other ocular conditions different from keratoconus. cognitive disability that limits the compression of the pain test as Down syndrome, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
laura Toro, MD
Phone
+52154421700
Ext
3710
Email
lauratorog@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Graue Hernandez, MD, MSc
Phone
+52154421700
Ext
3710
Email
egraueh@gmail.com
Facility Information:
Facility Name
Instituto de oftalmología conde de Valenciana
City
Mexico City
ZIP/Postal Code
06800
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Graue Hernandez, MD MSc
Phone
+52 5554421700
Ext
3710
Email
egraueh@gmail.com
First Name & Middle Initial & Last Name & Degree
Laura Toro, MD
Phone
+52 5554421700
Ext
3710
Email
lauratorog@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25648281
Citation
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Riboflavin at 4ºC for the Management of Pain After Crosslinking for Keratoconus Patients

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