KeratoconusPED-CXLNCT02008175
Conventional Collagen Crosslinking in Young Keratoconus
A study testing Conventional CXL in people with Keratoconus, run by Vasan Eye Care Hospital at 1 site in India.
Trial summary
Keratoconus is a chronic progressive non - inflammatory disorder characterised by progressive steepening and thinning of cornea and high myopic astigmatism, accounting for poor visual acuity in such individuals. Keratoconus seems to be more advanced on presentation, in young patients. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Conventional CXL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 18 years and below.
- Patients diagnosed to have keratoconus at presentation and willing for follow - up at regular intervals post treatment.
Who cannot join
- Any disease causing abnormal topography other than keratoconus.
- Any ocular condition predisposing towards poor vision (retinal , lens problems)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Conventional Collagen Crosslinking in Young Keratoconus.
Keratoconus is a chronic progressive non - inflammatory disorder characterised by progressive steepening and thinning of cornea and high myopic astigmatism, accounting for poor visual acuity in such individuals. Keratoconus seems to be more advanced on presentation, in young patients.
The investigators intend to evaluate the effectiveness of conventional collagen cross linking in young patients diagnosed with keratoconus.
Read the detailed description
Keratoconus is progressive ectatic corneal disorder characterised by progressive corneal thinning, steep corneal curvatures and usually associated with high irregular myopic astigmatism.
The major problems concerning keratoconus in young patients are;
- Rapid rates of progression in young keratoconic corneas as compared to adults.
- Poor biomechanical properties of young corneas.
- Poor quality of vision, which predisposes to a very poor quality of life.
- High rates of complications and failure post keratoplasty in young patients.
The investigators intend to evaluate the effectiveness of conventional collagen crosslinking in young patients with keratoconus with regards to keratometric indices and visual acuity.
- Conditions
- Keratoconus
- Being tested
- Conventional CXL
- Keywords
- paediatric, keratoconus, collagen cross linking
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional CXLRadiation
Also called Conventional collagen cross linking, C3R, Dresden protocol.
Crosslinking was done according to the standard protocol using hypo-osmolar riboflavin (<0.1%) to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/cm2 with riboflavin and distilled water alternated every 2 minutes was used for the procedure..
| Study group | Role | What they receive |
|---|---|---|
| Conventional CXL | Experimental | Crosslinking was done according to the standard protocol using hypo-osmolar riboflavin to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/sq.cm with riboflavin and distilled water alternated every 2 minutes was used for the procedure. Receives: Radiation: Conventional CXL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Keratometric indices
The keratometric readings in the steepest and flattest meridians, along with the average K readings were compared pre and post treatment using conventional collagen cross linking technique at 1 month post cross linking.
Measured: 1 months
Secondary outcomes (1)
Improvement in vision
Comparison of visual rehabilitation was done as improvements noted in Snellen line numbers and best corrected visual acuity (B.C.V.A) converted to decimals, pre and post treatment at 1,3,6,12 months post treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vasan Eye Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.ANAND PARTHASARATHY, Dr. Ramesh Hariharan, Vasan Eye Care Hospital
- Investigators
- Dr.Anand Parthasarathy, Principal investigator, Vasan Eye Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008175
- Sponsor's protocol ID
- PED_CXL
- Acronym
- PED-CXL
- Status last verified
- Dec 2013
- First submitted
- 2 Dec 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vinciguerra P, Albe E, Frueh BE, Trazza S, Epstein D. Two-year corneal cross-linking results in patients younger than 18 years with documented progressive keratoconus. Am J Ophthalmol. 2012 Sep;154(3):520-6. doi: 10.1016/j.ajo.2012.03.020. Epub 2012 May 24.
PubMed 22633357Chatzis N, Hafezi F. Progression of keratoconus and efficacy of pediatric [corrected] corneal collagen cross-linking in children and adolescents. J Refract Surg. 2012 Nov;28(11):753-8. doi: 10.3928/1081597X-20121011-01.
PubMed 23347367Caporossi A, Mazzotta C, Baiocchi S, Caporossi T, Denaro R, Balestrazzi A. Riboflavin-UVA-induced corneal collagen cross-linking in pediatric patients. Cornea. 2012 Mar;31(3):227-31. doi: 10.1097/ico.0b013e31822159f6.
PubMed 22420024
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Conventional Collagen Crosslinking in Young Keratoconus.
- ClinicalTrials.gov ID
- NCT02008175
- Acronym / sponsor ID
- PED-CXL / PED_CXL
- Conditions
- Keratoconus
- Keywords
- paediatric, keratoconus, collagen cross linking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vasan Eye Care HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Dec 2013 (estimated)
- 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.
Keratoconus is a chronic progressive non - inflammatory disorder characterised by progressive steepening and thinning of cornea and high myopic astigmatism, accounting for poor visual acuity in such individuals. Keratoconus seems to be more advanced on presentation, in young patients.
The investigators intend to evaluate the effectiveness of conventional collagen cross linking in young patients diagnosed with keratoconus.
Detailed description
Keratoconus is progressive ectatic corneal disorder characterised by progressive corneal thinning, steep corneal curvatures and usually associated with high irregular myopic astigmatism.
The major problems concerning keratoconus in young patients are;
- Rapid rates of progression in young keratoconic corneas as compared to adults.
- Poor biomechanical properties of young corneas.
- Poor quality of vision, which predisposes to a very poor quality of life.
- High rates of complications and failure post keratoplasty in young patients.
The investigators intend to evaluate the effectiveness of conventional collagen crosslinking in young patients with keratoconus with regards to keratometric indices and visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional CXL | Experimental | Radiation: Conventional CXLCrosslinking was done according to the standard protocol using hypo-osmolar riboflavin to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/sq.cm with riboflavin and distilled water alternated every 2 minutes was used for the procedure. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients aged 18 years and below.
- Patients diagnosed to have keratoconus at presentation and willing for follow - up at regular intervals post treatment.
Key exclusion criteria (2 listed)
- Any disease causing abnormal topography other than keratoconus.
- Any ocular condition predisposing towards poor vision (retinal , lens problems)
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 |
|---|---|---|
| Conventional CXLAlso: Conventional collagen cross linking, C3R, Dresden protocol.Crosslinking was done according to the standard protocol using hypo-osmolar riboflavin (<0.1%) to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/cm2 with riboflavin and distilled water alternated every 2 minutes was used for the procedure.. | Radiation | Conventional CXL |
Primary outcome
Change in Keratometric indices
Time frame: 1 months
The keratometric readings in the steepest and flattest meridians, along with the average K readings were compared pre and post treatment using conventional collagen cross linking technique at 1 month post cross linking.
1 secondary outcome
Improvement in vision
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Background: PubMed 22633357Vinciguerra P, Albe E, Frueh BE, Trazza S, Epstein D. Two-year corneal cross-linking results in patients younger than 18 years with documented progressive keratoconus. Am J Ophthalmol. 2012 Sep;154(3):520-6. doi: 10.1016/j.ajo.2012.03.020. Epub 2012 May 24.
- Background: PubMed 23347367Chatzis N, Hafezi F. Progression of keratoconus and efficacy of pediatric [corrected] corneal collagen cross-linking in children and adolescents. J Refract Surg. 2012 Nov;28(11):753-8. doi: 10.3928/1081597X-20121011-01.
- Background: PubMed 22420024Caporossi A, Mazzotta C, Baiocchi S, Caporossi T, Denaro R, Balestrazzi A. Riboflavin-UVA-induced corneal collagen cross-linking in pediatric patients. Cornea. 2012 Mar;31(3):227-31. doi: 10.1097/ico.0b013e31822159f6.
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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. This study is not recruiting at the moment.
Dr.Anand Parthasarathy principal investigator
Vasan Eye Care Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional CXL in people with Keratoconus, run by Vasan Eye Care Hospital at 1 site in India.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Dec 2013. 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 India. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Keratometric indices (time frame: 1 months). 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 NCT02008175, which also lists 3 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 16 Dec 2013; AzTrials last refreshed its copy on 30 Oct 2026.