Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia (CXL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01112072 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 28, 2010
Last Update Posted
: January 25, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keratoconus Corneal Ectasia | Drug: Riboflavin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking and Intacs for Treatment of Keratoconus and Corneal Ectasia |
Study Start Date : | April 2010 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Intacs combined with CXL
Intacs placement followed by collagen crosslinking with UV light and riboflavin
|
Drug: Riboflavin
Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL.
Other Names:
|
Active Comparator: Intacs followed by CXL
Intacs placement, to be followed by corneal collagen crosslinking with UV light and riboflavin 3 months later
|
Drug: Riboflavin
Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL.
Other Names:
|
- Maximum keratometry [ Time Frame: 1 year ]
- Best Corrected Visual Acuity [ Time Frame: 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 21 years of age or older
- Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK)
- Subjects who meet the manufacturer's nomogram recommendations for Intacs segments
- Topography consistent with keratoconus or post-surgical corneal ectasia.
- BSCVA worse than 20/20 (<55 letters on ETDRS chart)
Exclusion Criteria:
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
- Corneal pachymetry ≤ 400 microns at the thinnest point measured by Pentacam in the eye(s) to be treated when the isotonic riboflavin solution is used or ≤ 300 microns when the hypotonic riboflavin us used, provided that the corneal thickness after treatment with the hypotonic riboflavin solution is > 400 microns. Corneal pachymetry ≤ 450 microns at the proposed insertion site for the Intacs
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
- History of corneal disease
- History of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Subjects with nystagmus or any other condition that would prevent a steady gaze during the CXL and Intacs treatment or other diagnostic tests.
- Subjects with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.

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): NCT01112072
United States, New Jersey | |
Cornea and Laser Eye Institute | |
Teaneck, New Jersey, United States, 07666 |
Principal Investigator: | Peter Hersh, M.D. | Cornea and Laser Eye Institute |
Responsible Party: | Cornea and Laser Eye Institute |
ClinicalTrials.gov Identifier: | NCT01112072 History of Changes |
Other Study ID Numbers: |
CLEI-Intacs-CXL |
First Posted: | April 28, 2010 Key Record Dates |
Last Update Posted: | January 25, 2018 |
Last Verified: | January 2018 |
Keywords provided by Cornea and Laser Eye Institute:
keratoconus corneal ectasia collagen crosslinking |
riboflavin cornea ultraviolet |
Additional relevant MeSH terms:
Keratoconus Dilatation, Pathologic Corneal Diseases Eye Diseases Pathological Conditions, Anatomical Riboflavin Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents |