Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to determine whether mechanical compression of the cornea during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve the optical outcomes of the treatment.
The study is designed as a prospective, open, randomized controlled trial involving patients aged 18-28 years of both genders with uni- or bilateral keratoconus planned for routine corneal crosslinking at the Department of Ophthalmology, Umeå University Hospital, Umeå, Sweden. The study involves 30+30 eyes with keratoconus, which are randomized to receive either conventional corneal crosslinking (n=30) using the Dresden protocol or a modified treatment - corneal reshaping and crosslinking (n=30), where a rigid contact lens is sutured to the cornea during the treatment to flatten the corneal curvature and potentially improve the optical outcome after the treatment. Patients are randomized utilizing a list of unique random numbers between 1 and 60. All patients are informed about the procedures before consenting to participate in the study. The study also involves 60 eyes of healthy age- and sex-matched control subjects.
At baseline, before treatment, each eye is evaluated with autorefractometer measurement, best spectacle-corrected LogMAR visual acuity, Pentacam Scheimpflug photography, Goldmann applanation tonometry and biomicroscopy. The corneal biomechanical characteristics are assessed with applanation resonance tonometry and the ocular response analyzer. The investigations are repeated at 1 month, 6 months, 2 years and 5 years after the treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneal reshaping/crosslinking (CRXL) | Experimental | Corneal crosslinking with compression of the cornea using a sutured rigid contact lens during the treatment. |
|
| Corneal crosslinking (CXL) | Active Comparator | Standard corneal crosslinking using the Dresden protocol. |
|
| Control group to CRXL | No Intervention | Healthy subjects, age- and sex-matched to the CRXL group. | |
| Control group to CXL | No Intervention | Healthy subjects, age- and sex-matched to the CXL group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal reshaping/crosslinking (CRXL) | Procedure | The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. A flat, rigid contact lens is sutured to the cornea and the cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in refraction | Refractive errors, including lower and higher order aberrations in the cornea | 1, 6, 24 and 60 months after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ETDRS LogMAR visual acuity | Uncorrected and best spectacle corrected visual acuity measured with the Early treatment diabetic retinopathy study, graded in logarithmic values of the minimal angle of resolution | 1, 6, 24 and 60 months after the treatment |
| Change from baseline in corneal biomechanical stability measured with ORA |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anders Behndig, Professor | Umeå University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24628999 | Background | Beckman Rehnman J, Behndig A, Hallberg P, Linden C. Initial results from mechanical compression of the cornea during crosslinking for keratoconus. Acta Ophthalmol. 2014 Nov;92(7):644-9. doi: 10.1111/aos.12380. Epub 2014 Mar 15. | |
| 25171564 | Background | Beckman Rehnman J, Behndig A, Hallberg P, Linden C. Increased corneal hysteresis after corneal collagen crosslinking: a study based on applanation resonance technology. JAMA Ophthalmol. 2014 Dec;132(12):1426-32. doi: 10.1001/jamaophthalmol.2014.3029. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Corneal Crosslinking (CXL) | Procedure | The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. The cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes. |
|
Biomechanical stability assessed with the ocular response analyzer |
| 1, 6, 24 and 60 months after the treatment |
| Change from baseline in corneal biomechanical stability measured with ART | Biomechanical stability assessed with the applanation resonance tonometer | 1, 6, 24 and 60 months after the treatment |
| Change from baseline in corneal biomechanical stability measured with GAT | Biomechanical stability assessed with the Goldmann applanation tonometer | 1, 6, 24 and 60 months after the treatment |
| Change from baseline in corneal densitometry | Corneal light reflectivity (back scatter) assessed with the Pentacam HR Scheimpflug camera | 1, 6, 24 and 60 months after the treatment |
| 21873026 | Result | Beckman Rehnman J, Janbaz CC, Behndig A, Linden C. Spatial distribution of corneal light scattering after corneal collagen crosslinking. J Cataract Refract Surg. 2011 Nov;37(11):1939-44. doi: 10.1016/j.jcrs.2011.05.028. Epub 2011 Aug 27. |
| 26312777 | Derived | Rehnman JB, Linden C, Hallberg P, Behndig A. Treatment Effect and Corneal Light Scattering With 2 Corneal Cross-linking Protocols: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 Nov;133(11):1254-60. doi: 10.1001/jamaophthalmol.2015.2852. |