Corneal Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneas
NCT ID: NCT02943967
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
44 participants
INTERVENTIONAL
2010-01-31
2014-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Combining PRK and CXL is already done in patients with keratoconus and suspected keratoconus.
This combined procedure uses the principle that CXL stiffen the cornea making it possible to reduce corneal thickness with PRK without weakening corneal strength. Literature show better results, in keratoconus, with simultaneous procedures. Guedj et al performed PRK in keratoconus suspects and within 5 years he did not found any corneal ectasia.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CXL + PRK group
Corneal cross-linking surgery is perfomed in one eye : deepithelization of the cornea and instillation of 0,1% riboflavin (ophthalmos - Brazil) for 30 minutes and UVA for irradiated for 30 minutes with ultraviolet-A of 365nm light with an irradiance of 3 mW/cm2 using Xlink (Opto - São Carlos) Photorefractive keratotomy will be perfomed in the same eye using excimer laser Ladarvision (Alcon - USA) with 0,02 % mitomicin for 30 seconds (Ophthalmos - Brasil) simultaneously with the other eye.
Both procedures will have the same post operative treatment :
gatifloxacin 0,3% 6/6h for 10 days prednisolone acetate 0,12% 6/6h por 14 days
CXL + PRK group
Corneal cross-linking with subsequent photorefractive keratotomy after 6 months was performed in one eye
PRK group
Photorefractive keratotomy will be perfomed in the fellow eye using excimer laser Ladarvision (Alcon - USA) with 0,02 % mitomicin for 30 seconds (Ophthalmos - Brasil) simultaneously with the other eye.
Both procedures will have the same post operative treatment :
gatifloxacin 0,3% 6/6h for 10 days prednisolone acetate 0,12% 6/6h por 14 days
PRK group
Photorefractive keratotomy alone was performed in contra lateral eyes
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CXL + PRK group
Corneal cross-linking with subsequent photorefractive keratotomy after 6 months was performed in one eye
PRK group
Photorefractive keratotomy alone was performed in contra lateral eyes
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* corneal thickness of 440 micra at the thinnest point
* inferior-to-superior index (I-S) between 1.0D and 1.4D
* maximum keratometric steepness \< 47.00D
* stable refraction more than 1 year.
Exclusion Criteria
* previous eye surgery
* previous eye trauma
* confirmed pregnancy
23 Years
51 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal University of São Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mauro Campos
medical doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mauro Campos, MD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Federal University of São Paulo
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cheema AS, Mozayan A, Channa P. Corneal collagen crosslinking in refractive surgery. Curr Opin Ophthalmol. 2012 Jul;23(4):251-6. doi: 10.1097/ICU.0b013e3283543cbd.
Raiskup F, Theuring A, Pillunat LE, Spoerl E. Corneal collagen crosslinking with riboflavin and ultraviolet-A light in progressive keratoconus: ten-year results. J Cataract Refract Surg. 2015 Jan;41(1):41-6. doi: 10.1016/j.jcrs.2014.09.033.
Carones F, Vigo L, Scandola E, Vacchini L. Evaluation of the prophylactic use of mitomycin-C to inhibit haze formation after photorefractive keratectomy. J Cataract Refract Surg. 2002 Dec;28(12):2088-95. doi: 10.1016/s0886-3350(02)01701-7.
Randleman JB, Woodward M, Lynn MJ, Stulting RD. Risk assessment for ectasia after corneal refractive surgery. Ophthalmology. 2008 Jan;115(1):37-50. doi: 10.1016/j.ophtha.2007.03.073. Epub 2007 Jul 12.
Navas A, Ariza E, Haber A, Fermon S, Velazquez R, Suarez R. Bilateral keratectasia after photorefractive keratectomy. J Refract Surg. 2007 Nov;23(9):941-3. doi: 10.3928/1081-597X-20071101-14.
Guedj M, Saad A, Audureau E, Gatinel D. Photorefractive keratectomy in patients with suspected keratoconus: five-year follow-up. J Cataract Refract Surg. 2013 Jan;39(1):66-73. doi: 10.1016/j.jcrs.2012.08.058. Epub 2012 Oct 24.
Koller T, Mrochen M, Seiler T. Complication and failure rates after corneal crosslinking. J Cataract Refract Surg. 2009 Aug;35(8):1358-62. doi: 10.1016/j.jcrs.2009.03.035.
Abib FC, Holzchuh R, Schaefer A, Schaefer T, Godois R. The endothelial sample size analysis in corneal specular microscopy clinical examinations. Cornea. 2012 May;31(5):546-50. doi: 10.1097/ICO.0b013e3181cc7961.
Kontadakis GA, Kankariya VP, Tsoulnaras K, Pallikaris AI, Plaka A, Kymionis GD. Long-Term Comparison of Simultaneous Topography-Guided Photorefractive Keratectomy Followed by Corneal Cross-linking versus Corneal Cross-linking Alone. Ophthalmology. 2016 May;123(5):974-83. doi: 10.1016/j.ophtha.2016.01.010. Epub 2016 Feb 17.
Camellin M, Guidotti JM, Arba Mosquera S. Corneal-Wavefront guided transepithelial photorefractive keratectomy after corneal collagen cross linking in keratoconus. J Optom. 2017 Jan-Mar;10(1):52-62. doi: 10.1016/j.optom.2016.02.001. Epub 2016 Mar 21.
Shaheen MS, Shalaby Bardan A, Pinero DP, Ezzeldin H, El-Kateb M, Helaly H, Khalifa MA. Wave Front-Guided Photorefractive Keratectomy Using a High-Resolution Aberrometer After Corneal Collagen Cross-Linking in Keratoconus. Cornea. 2016 Jul;35(7):946-53. doi: 10.1097/ICO.0000000000000888.
Tomita M, Yoshida Y, Yamamoto Y, Mita M, Waring G 4th. In vivo confocal laser microscopy of morphologic changes after simultaneous LASIK and accelerated collagen crosslinking for myopia: one-year results. J Cataract Refract Surg. 2014 Jun;40(6):981-90. doi: 10.1016/j.jcrs.2013.10.044.
Guell JL, Verdaguer P, Elies D, Gris O, Manero F. Persistent stromal scar after PRK and CXL: different preoperative findings, similar complication. J Refract Surg. 2015 Mar;31(3):211-2. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2088/88
Identifier Type: -
Identifier Source: org_study_id