KeratoconusTICLNCT02833649
Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus
A study testing Toric Implantable collamer Lens in people with Keratoconus, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
To report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data preoperation, and compare with a similar postoperative outcomes) with the Toric Implantable Contact Lens (TICL) for Stable keratoconus. Read more about this study
- Who is it for?
- Ages 25 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Toric Implantable collamer Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIran
- Study dates
- Dec 2011to Dec 2016
- 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 25 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age (25-38).
- Stable refraction was distinctive by 6 subjective refractions within ± 0.50 diopters(D) of spherical equivalent during 6 months after CXL.
- best spectacle-corrected visual acuity (BCVA) of +0.4 LogMAR (20/40) or better, -clear central cornea.
- normal anterior chamber depth at least 3 mm to endothelium .
- intraocular pressure (IOP)<20 mm Hg and preoperative endothelial cell count related to age and the anterior chamber depth with regard to Food and Drug Administration recommendations.
- Width of Angle greater than 30°, a pupil diameter of less than 6.25 mm.
Who cannot join
- Patients with central corneal thickness of less than 450 μm.
- endothelial cell count of less than 2,000 cells/mm2 .
- anterior chamber depth of <3 mm from endothelium to anterior capsule .
- Corneal opacification or scars, cataract, retinal detachment, glaucoma, retinopathy, macular degeneration, neuro ophthalmic diseases or ocular inflammation, history of keratitis (any form), peripheral marginal degeneration, previous corneal and/or intraocular surgeries, and autoimmune and/or connective tissue disease. The central corneal thickness limit of 450 μm would account for around 400 μm of remaining stromal thickness after removal of the epithelium, which is considered as the safety thickness for the residual stroma to avoid endothelial cell damage during the CXL procedure.
Trial locations and contacts
1 site in 1 country.
Farideh Doroodgar, MD contact
Iran1 site, 1 recruiting
- Recruiting
Farideh Doroodgar
Tehran, Tehran Province
Farideh Doroodgar, MD, +989125259912, farinaz_144@yahoo.com
About this study
Official title: Comparative Analysis of the Visual Performance in Patients With Stable Keratoconus After Implantation of the Toric Implantable Collamer Lens (TICL).
To report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data preoperation, and compare with a similar postoperative outcomes) with the Toric Implantable Contact Lens (TICL) for Stable keratoconus. Investigators will study the four-year follow-up from this standardized, multi-center clinical investigation, support from clinical and optical viewpoints TICL implantation, in stable keratoconus.
- Conditions
- Keratoconus
- Being tested
- Toric Implantable collamer Lens
- Keywords
- Keratoconus, Crosslinking, Toric ICL
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toric Implantable collamer LensDevice
Also called TICL
The toric implantable collamer lens (TICL) is conventionally indicated for the Correcting the refractive error in keratoconus using the TICL is an off label use of the lens.
| Study group | Role | What they receive |
|---|---|---|
| Toric Implantable contact Lens | Experimental | The Visian implantable collamer lens (Staar Surgical AG, Nidau, Switzerland), is a monoblock single-piece plate haptic lens made of collamer (an extremely hydrophilic and highly biocompatible flexible collagen copolymer with a refractive index of 1.452 that is permeable to oxygen and nutrients Receives: Device: Toric Implantable collamer Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (UCVA,BCVA) by Snellen chart
Measured: Up to 4 years after surgery
Secondary outcomes (5)
Refractive error by Auto Kerato-Refractometer
Measured: Until 4 years after surgery
Defocus curve by Phoropter
Measured: Up to 4 years after surgery
Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire
Measured: up to 4 years after surgery
Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China.
Measured: up to 4 years after surgery
Aberrometry by Ray Tracing
Measured: Up to 4 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startDec 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farideh Doroodgar, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833649
- Sponsor's protocol ID
- ShaheedBU
- Acronym
- TICL
- Status last verified
- Jul 2016
- First submitted
- 4 Jul 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Doroodgar F, Niazi F, Sanginabadi A, Niazi S, Baradaran-Rafii A, Alinia C, Azargashb E, Ghoreishi M. Comparative analysis of the visual performance after implantation of the toric implantable collamer lens in stable keratoconus: a 4-year follow-up after sequential procedure (CXL+TICL implantation). BMJ Open Ophthalmol. 2017 Sep 28;2(1):e000090. doi: 10.1136/bmjophth-2017-000090. eCollection 2017.
PubMed 29354720
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Visual Performance in Patients With Stable Keratoconus After Implantation of the Toric Implantable Collamer Lens (TICL).
- ClinicalTrials.gov ID
- NCT02833649
- Acronym / sponsor ID
- TICL / ShaheedBU
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Crosslinking, Toric ICL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Jul 2016 (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.
To report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data preoperation, and compare with a similar postoperative outcomes) with the Toric Implantable Contact Lens (TICL) for Stable keratoconus. Investigators will study the four-year follow-up from this standardized, multi-center clinical investigation, support from clinical and optical viewpoints TICL implantation, in stable keratoconus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toric Implantable contact Lens | Experimental | Device: Toric Implantable collamer LensThe Visian implantable collamer lens (Staar Surgical AG, Nidau, Switzerland), is a monoblock single-piece plate haptic lens made of collamer (an extremely hydrophilic and highly biocompatible flexible collagen copolymer with a refractive index of 1.452 that is permeable to oxygen and nutrients |
Who may qualify
- Ages
- 25 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age (25-38).
- Stable refraction was distinctive by 6 subjective refractions within ± 0.50 diopters(D) of spherical equivalent during 6 months after CXL.
- best spectacle-corrected visual acuity (BCVA) of +0.4 LogMAR (20/40) or better, -clear central cornea.
- normal anterior chamber depth at least 3 mm to endothelium .
- intraocular pressure (IOP)<20 mm Hg and preoperative endothelial cell count related to age and the anterior chamber depth with regard to Food and Drug Administration recommendations.
Key exclusion criteria (4 listed)
- Patients with central corneal thickness of less than 450 μm.
- endothelial cell count of less than 2,000 cells/mm2 .
- anterior chamber depth of <3 mm from endothelium to anterior capsule .
- Corneal opacification or scars, cataract, retinal detachment, glaucoma, retinopathy, macular degeneration, neuro ophthalmic diseases or ocular inflammation, history of keratitis (any form), peripheral marginal degeneration, previous corneal and/or intraocular surgeries, and autoimmune and/or connective tissue disease. The central corneal thickness limit of 450 μm would account for around 400 μm of remaining stromal thickness after removal of the epithelium, which is considered as the safety thickness for the residual stroma to avoid endothelial cell damage during the CXL procedure.
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 |
|---|---|---|
| Toric Implantable collamer LensAlso: TICLThe toric implantable collamer lens (TICL) is conventionally indicated for the Correcting the refractive error in keratoconus using the TICL is an off label use of the lens. | Device | Toric Implantable contact Lens |
Primary outcome
Visual acuity (UCVA,BCVA) by Snellen chart
Time frame: Up to 4 years after surgery
5 secondary outcomes
Refractive error by Auto Kerato-Refractometer
Time frame: Until 4 years after surgery
Defocus curve by Phoropter
Time frame: Up to 4 years after surgery
Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire
Time frame: up to 4 years after surgery
Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China.
Time frame: up to 4 years after surgery
Aberrometry by Ray Tracing
Time frame: Up to 4 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Derived from this study: PubMed 29354720Doroodgar F, Niazi F, Sanginabadi A, Niazi S, Baradaran-Rafii A, Alinia C, Azargashb E, Ghoreishi M. Comparative analysis of the visual performance after implantation of the toric implantable collamer lens in stable keratoconus: a 4-year follow-up after sequential procedure (CXL+TICL implantation). BMJ Open Ophthalmol. 2017 Sep 28;2(1):e000090. doi: 10.1136/bmjophth-2017-000090. eCollection 2017.
- Individual participant dataSharing planned: Undecided
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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.
Farideh Doroodgar, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toric Implantable collamer Lens in people with Keratoconus, run by Shahid Beheshti University at 1 site in Iran.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Jul 2016. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farideh Doroodgar, MD (farinaz_144@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (UCVA,BCVA) by Snellen chart (time frame: Up to 4 years after surgery). 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 NCT02833649, which also lists 1 linked publication.
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 15 Jul 2016.