Myopic RegressionNCT01506635
Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After LASIK: a Randomized Clinical Trial
A study testing Timolol in people with Myopic Regression, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myopic Regression
- What is being tested?
- Timolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIran
- Study dates
- Mar 2010to Dec 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with myopic regression equal or more than 0.5 D with minimum age of 20 years,
- cylinder ≤ -1.00 D,
- corrected distance visual acuity (CDVA) of at least 20/40 were included.
Who cannot join
- Patients with a history of previous ocular surgery,
- keratoconus or any ectatic corneal disorder,
- keratoconus suspect by topography,
- preoperative corneal opacity,
- any corneal dystrophies,
- presence of pterygium,
Show all 14Show fewer
- retinal disorders,
- collagen vascular disorders,
- diabetes mellitus,
- glaucoma,
- cataract,
- pregnancy,
- breast feeding
- systemic corticosteroid therapy were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser in Situ Keratomileusis: A Randomized Clinical Trial
In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK
- Conditions
- Myopic Regression
- Being tested
- Timolol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimololDrug
PlaceboDrug
artificial tear twice a day
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | included patients who received artificial tear twice a day as control group. Receives: Drug: Placebo |
| Timolol group | Experimental | included the patients with myopic regression who received timolol 0.5% eye drop twice a day Receives: Drug: Timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Equivalent
Effect of timolol use in timolol group will be compared with placebo group at month 6. Moreover, the changes of intragroup spherical equivalent will be assessed in both group 6 months after timolol application.
Measured: spherical equivalent at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
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 Myopic RegressionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506635
- Sponsor's protocol ID
- 8902
- Status last verified
- Oct 2009
- First submitted
- 4 Jan 2012
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shojaei A, Eslani M, Vali Y, Mansouri M, Dadman N, Yaseri M. Effect of timolol on refractive outcomes in eyes with myopic regression after laser in situ keratomileusis: a prospective randomized clinical trial. Am J Ophthalmol. 2012 Nov;154(5):790-798.e1. doi: 10.1016/j.ajo.2012.05.013. Epub 2012 Aug 28.
PubMed 22935601
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser in Situ Keratomileusis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01506635
- Acronym / sponsor ID
- 8902
- Conditions
- Myopic Regression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Jan 2012 (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.
In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Placeboincluded patients who received artificial tear twice a day as control group. |
| Timolol group | Experimental | Drug: Timololincluded the patients with myopic regression who received timolol 0.5% eye drop twice a day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with myopic regression equal or more than 0.5 D with minimum age of 20 years,
- cylinder ≤ -1.00 D,
- corrected distance visual acuity (CDVA) of at least 20/40 were included.
Key exclusion criteria (14 listed)
- Patients with a history of previous ocular surgery,
- keratoconus or any ectatic corneal disorder,
- keratoconus suspect by topography,
- preoperative corneal opacity,
- any corneal dystrophies,
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 |
|---|---|---|
| Timolol | Drug | Timolol group |
| Placeboartificial tear twice a day | Drug | Control group |
Primary outcome
Spherical Equivalent
Time frame: spherical equivalent at month 6
Effect of timolol use in timolol group will be compared with placebo group at month 6. Moreover, the changes of intragroup spherical equivalent will be assessed in both group 6 months after timolol application.
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 10 Jan 2012.
- Derived from this study: PubMed 22935601Shojaei A, Eslani M, Vali Y, Mansouri M, Dadman N, Yaseri M. Effect of timolol on refractive outcomes in eyes with myopic regression after laser in situ keratomileusis: a prospective randomized clinical trial. Am J Ophthalmol. 2012 Nov;154(5):790-798.e1. doi: 10.1016/j.ajo.2012.05.013. Epub 2012 Aug 28.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timolol in people with Myopic Regression, run by Shahid Beheshti University of Medical Sciences 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 3 inclusion and 14 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 10 Jan 2012. 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. 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?
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?
Spherical Equivalent (time frame: spherical equivalent at month 6). 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 NCT01506635, 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 10 Jan 2012.