MyopiaNCT01088568
Randomized, Prospective Comparison of the Outcome of Toric Implantable Contact Lens (TICL) and Q-LASIK for the Correction of Myopia With Astigmatism
A study testing the implantation of toric implantable collamer lens and customized laser-assisted in situ keratomileusis in people with Myopia and Astigmatism, run by Wenzhou Medical University at 1 site in China.
Trial summary
The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- the implantation of toric implantable collamer lens and customized laser-assisted in situ keratomileusis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2007to Mar 2010
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 21-45 years old
- Documented stable refraction for at least 1 year
- (-3.0 to -8.0D of myopia with -1.0 to -4.0D of astigmatism or SE from -3.5 to -10D
- BSCVA: 20/20 or better
- Pupil diameter: smaller than 7mm under mesopic condition
- Contact lens discontinued 3 weeks and 1 week for hard and soft wearers respectively
Who cannot join
- Evidence of progressive or acute disease
- Evidence of connective tissue disease or clinically significant atopic disease
- ACD less than 2.8mm from endothelium
- ECC less than 2200 cells/mm2
- Narrow angle of anterior chamber
- Residual stromal thickness less than 280 microns
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism
The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism.
- Conditions
- Myopia, Astigmatism
- Being tested
- the implantation of toric implantable collamer lens, customized laser-assisted in situ keratomileusis
- Keywords
- Keratomileusis, laser in situ, Phakic Intraocular Lenses, myopia, astigmatism, Implantable Collamer Lens, Toric
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the implantation of toric implantable collamer lensProcedure or surgery
Also called TICL
perform the implantation of toric implantable collamer lens for both eyes
customized laser-assisted in situ keratomileusisProcedure or surgery
Also called Q-factor customized LASIK
perform Q-factor customized laser-assisted in situ keratomileusis for both eyes
| Study group | Role | What they receive |
|---|---|---|
| TICL group | Experimental | Not described Receives: Procedure: the implantation of toric implantable collamer lens |
| LASIK group | Active comparator | Not described Receives: Procedure: customized laser-assisted in situ keratomileusis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK
Measured: 1week, 1,3,6 months
Secondary outcomes (1)
Comparing wavefront aberrometry of TICL vs Q-LASIK Comparing contrast sensitivity of TICL vs Q-LASIK Comparing patient satisfaction of TICL vs Q-LASIK
Measured: 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionMar 2010 (estimated)
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 MyopiaStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Staar Surgical Company
- Investigators
- Qin Mei Wang, Study director, Eye hospital of Wenzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088568
- Sponsor's protocol ID
- 20091231
- Status last verified
- Oct 2009
- First submitted
- 16 Mar 2010
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanders DR. Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters. J Refract Surg. 2007 Jun;23(6):537-53. doi: 10.3928/1081-597X-20070601-02.
PubMed 17598571Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.
PubMed 17172886Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea. 2003 May;22(4):324-31. doi: 10.1097/00003226-200305000-00009.
PubMed 12792475
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism
- ClinicalTrials.gov ID
- NCT01088568
- Acronym / sponsor ID
- 20091231
- Conditions
- Myopia, Astigmatism
- Keywords
- Keratomileusis, laser in situ, Phakic Intraocular Lenses, myopia, astigmatism, Implantable Collamer Lens, Toric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Staar Surgical Company
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2010 (estimated)
- First posted
- 17 Mar 2010 (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.
The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TICL group | Experimental | Procedure: the implantation of toric implantable collamer lens |
| LASIK group | Active comparator | Procedure: customized laser-assisted in situ keratomileusis |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 21-45 years old
- Documented stable refraction for at least 1 year
- (-3.0 to -8.0D of myopia with -1.0 to -4.0D of astigmatism or SE from -3.5 to -10D
- BSCVA: 20/20 or better
- Pupil diameter: smaller than 7mm under mesopic condition
Key exclusion criteria (6 listed)
- Evidence of progressive or acute disease
- Evidence of connective tissue disease or clinically significant atopic disease
- ACD less than 2.8mm from endothelium
- ECC less than 2200 cells/mm2
- Narrow angle of anterior chamber
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 |
|---|---|---|
| the implantation of toric implantable collamer lensAlso: TICLperform the implantation of toric implantable collamer lens for both eyes | Procedure or surgery | TICL group |
| customized laser-assisted in situ keratomileusisAlso: Q-factor customized LASIKperform Q-factor customized laser-assisted in situ keratomileusis for both eyes | Procedure or surgery | LASIK group |
Primary outcome
Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK
Time frame: 1week, 1,3,6 months
1 secondary outcome
Comparing wavefront aberrometry of TICL vs Q-LASIK Comparing contrast sensitivity of TICL vs Q-LASIK Comparing patient satisfaction of TICL vs Q-LASIK
Time frame: 1, 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2010.
- Background: PubMed 17598571Sanders DR. Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters. J Refract Surg. 2007 Jun;23(6):537-53. doi: 10.3928/1081-597X-20070601-02.
- Background: PubMed 17172886Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.
- Background: PubMed 12792475Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea. 2003 May;22(4):324-31. doi: 10.1097/00003226-200305000-00009.
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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.
Qin Mei Wang study director
Eye hospital of Wenzhou Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the implantation of toric implantable collamer lens and customized laser-assisted in situ keratomileusis in people with Myopia and Astigmatism, run by Wenzhou Medical University at 1 site in China.
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 6 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 17 Mar 2010. 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 China. 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?
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?
Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK (time frame: 1week, 1,3,6 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 NCT01088568, 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 17 Mar 2010.