KeratoconusEVOKENCT04584125
A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients
A study testing Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light and Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light in people with Keratoconus, run by Joseph B. Ciolino, MD at 1 site in United States.
Trial summary
This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-linked donor… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light and Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to provide written informed consent.
- Willing and able to comply with study assessments for the full duration of the study.
- Age ≥18 years but ≤50 years
- History of keratoconus (without a previous transplant) requiring keratoplasty
- Willing to commit to not having further cross-linking, corneal relaxing incisions, intacs, or corneal laser vision correction during the course of the study
Who cannot join
- Age < 18 years >50
- Inability to provide written informed consent and comply with study assessments for the full duration of the study
- Participation in another simultaneous interventional medical investigation or trial
- Systemic
- History of Stevens-Johnson syndrome or ocular pemphigoid
- Signs of current infection, including fever and current treatment with antibiotics
Show all 19Show fewer
- Pregnancy (positive pregnancy test) or lactating
- Pre-menopausal sexually active women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
- Recipient Eye
- Corneal or ocular surface infection within 30 days prior to study entry
- History of previous cross-linking
- History of previous corneal transplant
- Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
- Ocular or periocular malignancy
- Lid abnormalities that in the opinion of the investigator could confound the study results and these include clinically significant ectropion, lagophthalmos, cicatrization, entropion, and rosacea
- Neurotrophic cornea
- Monocular
- Uncontrolled glaucoma
- Glaucoma filtering devices or trabeculectomies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Joseph Ciolino, MD, 617-573-5575, Joseph_Ciolino@meei.harvard.edu
About this study
Official title: A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus
This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-linked donor corneas. Crosslinking is a procedure that stabilizes the biomechanical properties of the cornea; as a result, the cornea stiffens. It has been shown that this procedure stabilizes the cornea of patients with keratoconus or corneal ectasias. The FDA currently approves crosslinking for patients with progressive keratoconus and corneal ectasia following refractive surgery. Ex vivo crosslinking of donor corneal tissue for patients with keratoconus undergoing PK or DALK could stabilize the cornea and reduce the risk of high astigmatism and improve vision in patient with keratoconus.
Read the detailed description
The 15 clinical sites are expected to recruit cumulatively 216 cases over 18 months. Eligibility is assessed during a routine examination by an investigator. Informed consent will be obtained prior to collecting any information that is not part of usual care. Patients who meet all inclusion criteria and none of the exclusion criteria will be given the opportunity to participate in the study. Participants will be randomly assigned to the treatment group (cross-linked corneal tissue) or control group (non-cross-linked corneal tissue that has been exposed to riboflavin, but no ultraviolet light).
The investigator will request a cadaveric cornea from the study's central eye bank CorneaGen, which will prepare the cadaveric cornea. Participants will receive the cross-linked donor tissue or control donor tissue during surgery. Clinical sites, including surgeons, and participants will be masked to treatment assignment.
Participants will be followed up post-operatively by the site investigators as per the standard of care. This will include visits at 1 Day, 1 Week, 1 Month, 6 Months, 1 Year, 1.5 Years, 2 Years, and 2.5 Years post-surgery. Some participants may need to be seen more regularly for routine care. The investigators will monitor for systemic and ocular adverse events at all follow-up visits.
- Conditions
- Keratoconus
- Being tested
- Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light, Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light
- Keywords
- Corneal Crosslinking, Penetrating Keratoplasty, Deep Anterior Lamellar Keratoplasty
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV lightDrug
Also called PHOTREXA VISCOUS
A wavelength of 365 nm ultraviolet A light will be used to direct 5.4 J/cm2 using a beam diameter of 9.5mm to treat the de-epithelialized corneal surface of a donor cornea for 30 minutes. Every 2 minutes, the UV light will be used while another drop of riboflavin is applied on top of the donor cornea.
Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV lightDrug
Also called PHOTREXA VISCOUS
The corneal tissue for the control arm will be treated the same as the crosslinked tissue except that it will not be exposed to ultraviolet light. The donor cornea will be placed on an artificial anterior chamber maintainer and the epithelium will be removed mechanically. Riboflavin solution (0.1% riboflavin and 20% dextran supplied in a sterile, single-dose container) will be applied to the cornea every 2 minutes for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ex vivo cross linking of donor corneal tissue | Experimental | Treatment Arm: The donor corneal tissue used in the PK or DALK procedures will previously undergo ex vivo crosslinking. Receives: Drug: Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light |
| Non-cross-linked donor corneal tissue for keratoplasty | Sham comparator | Control Arm: The donor corneal tissue used in the PK or DALK procedures will not previously undergo ex vivo crosslinking. Receives: Drug: Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery.
- Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery
Measured: 130 weeks
Secondary outcomes (4)
• Best spectacle corrected visual acuity (BSCVA) with ETDRS methodology at 2.5 years (130 weeks) post-surgery
- Best spectacle corrected visual acuity (BSCVA) with ETDRS methodology at 2.5 years (130 weeks) post-surgery
Measured: 130 weeks
Manifest cylinder astigmatism at 130 weeks post-surgery
Manifest cylinder astigmatism at 130 weeks post-surgerykeratometry, anterior mean keratometry, posterior mean keratometry
Measured: 130 weeks
Uncorrected visual acuity (UCVA) 130 weeks post-surgery
Uncorrected visual acuity (UCVA) 130 weeks post-surgery
Measured: 130 weeks
Low-contrast BSCVA with ETDRS methodology at 130 weeks post-surgery
Low-contrast BSCVA with ETDRS methodology at 130 weeks post-surgerypermeable contact lens.
Measured: 130 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Jan 2027 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a multicenter, double-masked, parallel, and randomized study with a subsequent follow-up period of 30 months. 216 subjects (of any race or gender) who have keratoconus (between the ages of 18 and 50) will sign the consent for their first PK or DALK surgery in the study eye. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be given the opportunity to participate in the study. Subjects will either randomized to the treatment group (crosslinked corneal tissue) or control group (non-crosslinked corneal tissue that has been exposed to riboflavin, but no ultraviolet light).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph B. Ciolino, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary
- Investigators
- Joseph B Ciolino, Principal investigator, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584125
- Sponsor's protocol ID
- 2020P002132
- Acronym
- EVOKE
- Status last verified
- Apr 2026
- First submitted
- 5 Oct 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available.
Publications
Krachmer JH, Feder RS, Belin MW. Keratoconus and related noninflammatory corneal thinning disorders. Surv Ophthalmol. 1984 Jan-Feb;28(4):293-322. doi: 10.1016/0039-6257(84)90094-8.
PubMed 6230745Tan DT, Por YM. Current treatment options for corneal ectasia. Curr Opin Ophthalmol. 2007 Jul;18(4):284-9. doi: 10.1097/ICU.0b013e3281a7ecaa.
PubMed 17568202Yoshida J, Murata H, Miyai T, Shirakawa R, Toyono T, Yamagami S, Usui T. Characteristics and risk factors of recurrent keratoconus over the long term after penetrating keratoplasty. Graefes Arch Clin Exp Ophthalmol. 2018 Dec;256(12):2377-2383. doi: 10.1007/s00417-018-4131-5. Epub 2018 Sep 8.
PubMed 30196480Bechrakis N, Blom ML, Stark WJ, Green WR. Recurrent keratoconus. Cornea. 1994 Jan;13(1):73-7. doi: 10.1097/00003226-199401000-00012.
PubMed 8131410Abelson MB, Collin HB, Gillette TE, Dohlman CH. Recurrent keratoconus after keratoplasty. Am J Ophthalmol. 1980 Nov;90(5):672-6. doi: 10.1016/s0002-9394(14)75135-9.
PubMed 7004192Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.
PubMed 18471635Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.
PubMed 12719068Kelly TL, Williams KA, Coster DJ; Australian Corneal Graft Registry. Corneal transplantation for keratoconus: a registry study. Arch Ophthalmol. 2011 Jun;129(6):691-7. doi: 10.1001/archophthalmol.2011.7. Epub 2011 Feb 14.
PubMed 21320951Thompson RW Jr, Price MO, Bowers PJ, Price FW Jr. Long-term graft survival after penetrating keratoplasty. Ophthalmology. 2003 Jul;110(7):1396-402. doi: 10.1016/S0161-6420(03)00463-9.
PubMed 12867398Williams KA, Esterman AJ, Bartlett C, Holland H, Hornsby NB, Coster DJ. How effective is penetrating corneal transplantation? Factors influencing long-term outcome in multivariate analysis. Transplantation. 2006 Mar 27;81(6):896-901. doi: 10.1097/01.tp.0000185197.37824.35.
PubMed 16570014Williams KA, Lowe M, Bartlett C, Kelly TL, Coster DJ; All Contributors. Risk factors for human corneal graft failure within the Australian corneal graft registry. Transplantation. 2008 Dec 27;86(12):1720-4. doi: 10.1097/TP.0b013e3181903b0a.
PubMed 19104411Williams KA, Roder D, Esterman A, Muehlberg SM, Coster DJ. Factors predictive of corneal graft survival. Report from the Australian Corneal Graft Registry. Ophthalmology. 1992 Mar;99(3):403-14. doi: 10.1016/s0161-6420(92)31960-8.
PubMed 1565452Binder PS. The effect of suture removal on postkeratoplasty astigmatism. Am J Ophthalmol. 1988 Jun 15;105(6):637-45. doi: 10.1016/0002-9394(88)90057-8.
PubMed 3287939Limberg MB, Dingeldein SA, Green MT, Klyce SD, Insler MS, Kaufman HE. Corneal compression sutures for the reduction of astigmatism after penetrating keratoplasty. Am J Ophthalmol. 1989 Jul 15;108(1):36-42. doi: 10.1016/s0002-9394(14)73257-x.
PubMed 2665502Swinger CA. Postoperative astigmatism. Surv Ophthalmol. 1987 Jan-Feb;31(4):219-48. doi: 10.1016/0039-6257(87)90023-3.
PubMed 3554571
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus
- ClinicalTrials.gov ID
- NCT04584125
- Acronym / sponsor ID
- EVOKE / 2020P002132
- Conditions
- Keratoconus
- Keywords
- Corneal Crosslinking, Penetrating Keratoplasty, Deep Anterior Lamellar Keratoplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Joseph B. Ciolino, MDUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-linked donor corneas. Crosslinking is a procedure that stabilizes the biomechanical properties of the cornea; as a result, the cornea stiffens. It has been shown that this procedure stabilizes the cornea of patients with keratoconus or corneal ectasias. The FDA currently approves crosslinking for patients with progressive keratoconus and corneal ectasia following refractive surgery. Ex vivo crosslinking of donor corneal tissue for patients with keratoconus undergoing PK or DALK could stabilize the cornea and reduce the risk of high astigmatism and improve vision in patient with keratoconus.
Detailed description
The 15 clinical sites are expected to recruit cumulatively 216 cases over 18 months. Eligibility is assessed during a routine examination by an investigator. Informed consent will be obtained prior to collecting any information that is not part of usual care. Patients who meet all inclusion criteria and none of the exclusion criteria will be given the opportunity to participate in the study. Participants will be randomly assigned to the treatment group (cross-linked corneal tissue) or control group (non-cross-linked corneal tissue that has been exposed to riboflavin, but no ultraviolet light).
The investigator will request a cadaveric cornea from the study's central eye bank CorneaGen, which will prepare the cadaveric cornea. Participants will receive the cross-linked donor tissue or control donor tissue during surgery. Clinical sites, including surgeons, and participants will be masked to treatment assignment.
Participants will be followed up post-operatively by the site investigators as per the standard of care. This will include visits at 1 Day, 1 Week, 1 Month, 6 Months, 1 Year, 1.5 Years, 2 Years, and 2.5 Years post-surgery. Some participants may need to be seen more regularly for routine care. The investigators will monitor for systemic and ocular adverse events at all follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study is a multicenter, double-masked, parallel, and randomized study with a subsequent follow-up period of 30 months. 216 subjects (of any race or gender) who have keratoconus (between the ages of 18 and 50) will sign the consent for their first PK or DALK surgery in the study eye. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be given the opportunity to participate in the study. Subjects will either randomized to the treatment group (crosslinked corneal tissue) or control group (non-crosslinked corneal tissue that has been exposed to riboflavin, but no ultraviolet light).
| Arm | Type | Receives |
|---|---|---|
| Ex vivo cross linking of donor corneal tissue | Experimental | Drug: Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV lightTreatment Arm: The donor corneal tissue used in the PK or DALK procedures will previously undergo ex vivo crosslinking. |
| Non-cross-linked donor corneal tissue for keratoplasty | Sham comparator | Drug: Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV lightControl Arm: The donor corneal tissue used in the PK or DALK procedures will not previously undergo ex vivo crosslinking. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to provide written informed consent.
- Willing and able to comply with study assessments for the full duration of the study.
- Age ≥18 years but ≤50 years
- History of keratoconus (without a previous transplant) requiring keratoplasty
- Willing to commit to not having further cross-linking, corneal relaxing incisions, intacs, or corneal laser vision correction during the course of the study
Key exclusion criteria (19 listed)
- Age < 18 years >50
- Inability to provide written informed consent and comply with study assessments for the full duration of the study
- Participation in another simultaneous interventional medical investigation or trial
- Systemic
- History of Stevens-Johnson syndrome or ocular pemphigoid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV lightAlso: PHOTREXA VISCOUSA wavelength of 365 nm ultraviolet A light will be used to direct 5.4 J/cm2 using a beam diameter of 9.5mm to treat the de-epithelialized corneal surface of a donor cornea for 30 minutes. Every 2 minutes, the UV light will be used while another drop of riboflavin is applied on top of the donor cornea. | Drug | Ex vivo cross linking of donor corneal tissue |
| Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV lightAlso: PHOTREXA VISCOUSThe corneal tissue for the control arm will be treated the same as the crosslinked tissue except that it will not be exposed to ultraviolet light. The donor cornea will be placed on an artificial anterior chamber maintainer and the epithelium will be removed mechanically. Riboflavin solution (0.1% riboflavin and 20% dextran supplied in a sterile, single-dose container) will be applied to the cornea every 2 minutes for 30 minutes. | Drug | Non-cross-linked donor corneal tissue for keratoplasty |
Primary outcome
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery.
Time frame: 130 weeks
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery
4 secondary outcomes
• Best spectacle corrected visual acuity (BSCVA) with ETDRS methodology at 2.5 years (130 weeks) post-surgery
Time frame: 130 weeks
Manifest cylinder astigmatism at 130 weeks post-surgery
Time frame: 130 weeks
Uncorrected visual acuity (UCVA) 130 weeks post-surgery
Time frame: 130 weeks
Low-contrast BSCVA with ETDRS methodology at 130 weeks post-surgery
Time frame: 130 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 6230745Krachmer JH, Feder RS, Belin MW. Keratoconus and related noninflammatory corneal thinning disorders. Surv Ophthalmol. 1984 Jan-Feb;28(4):293-322. doi: 10.1016/0039-6257(84)90094-8.
- Background: PubMed 17568202Tan DT, Por YM. Current treatment options for corneal ectasia. Curr Opin Ophthalmol. 2007 Jul;18(4):284-9. doi: 10.1097/ICU.0b013e3281a7ecaa.
- Background: PubMed 30196480Yoshida J, Murata H, Miyai T, Shirakawa R, Toyono T, Yamagami S, Usui T. Characteristics and risk factors of recurrent keratoconus over the long term after penetrating keratoplasty. Graefes Arch Clin Exp Ophthalmol. 2018 Dec;256(12):2377-2383. doi: 10.1007/s00417-018-4131-5. Epub 2018 Sep 8.
- Background: PubMed 8131410Bechrakis N, Blom ML, Stark WJ, Green WR. Recurrent keratoconus. Cornea. 1994 Jan;13(1):73-7. doi: 10.1097/00003226-199401000-00012.
- Background: PubMed 7004192Abelson MB, Collin HB, Gillette TE, Dohlman CH. Recurrent keratoconus after keratoplasty. Am J Ophthalmol. 1980 Nov;90(5):672-6. doi: 10.1016/s0002-9394(14)75135-9.
- Background: PubMed 18471635Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.
- Background: PubMed 12719068Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.
- Background: PubMed 21320951Kelly TL, Williams KA, Coster DJ; Australian Corneal Graft Registry. Corneal transplantation for keratoconus: a registry study. Arch Ophthalmol. 2011 Jun;129(6):691-7. doi: 10.1001/archophthalmol.2011.7. Epub 2011 Feb 14.
- Background: PubMed 12867398Thompson RW Jr, Price MO, Bowers PJ, Price FW Jr. Long-term graft survival after penetrating keratoplasty. Ophthalmology. 2003 Jul;110(7):1396-402. doi: 10.1016/S0161-6420(03)00463-9.
- Background: PubMed 16570014Williams KA, Esterman AJ, Bartlett C, Holland H, Hornsby NB, Coster DJ. How effective is penetrating corneal transplantation? Factors influencing long-term outcome in multivariate analysis. Transplantation. 2006 Mar 27;81(6):896-901. doi: 10.1097/01.tp.0000185197.37824.35.
- Background: PubMed 19104411Williams KA, Lowe M, Bartlett C, Kelly TL, Coster DJ; All Contributors. Risk factors for human corneal graft failure within the Australian corneal graft registry. Transplantation. 2008 Dec 27;86(12):1720-4. doi: 10.1097/TP.0b013e3181903b0a.
- Background: PubMed 1565452Williams KA, Roder D, Esterman A, Muehlberg SM, Coster DJ. Factors predictive of corneal graft survival. Report from the Australian Corneal Graft Registry. Ophthalmology. 1992 Mar;99(3):403-14. doi: 10.1016/s0161-6420(92)31960-8.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph B Ciolino principal investigator
Massachusetts Eye and Ear
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light and Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light in people with Keratoconus, run by Joseph B. Ciolino, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph B Ciolino, MD ((617) 573-3938, Joseph_Ciolino@MEEI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery. (time frame: 130 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584125, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.