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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2015/07/005966 |
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Date of registration:
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06-07-2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Retrospective study to find out the incidence and causes leading to removal of ICL(a specific type of lens implanted in the eye to correct short sightedness, after its successful implantation.
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Scientific title:
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Retrospctive analysis of incidence and factors responsible for implantable collamer lens (icl) explantation following uneventful surgery. |
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Date of first enrolment:
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31-03-2010 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11476 |
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Study type:
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Observational |
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Study design:
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Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Rahul Pandey
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Address:
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Nethradhama Superspeciality eye hospital, 256/14, Jayanagar 7th block, Bangalore. 256/14, Jayanagar 7th block, Bangalore 560082.
560082
Bangalore, KARNATAKA
India |
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Telephone:
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9731809663 |
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Email:
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drrahulp2012@gmail.com |
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Affiliation:
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Nethradhama Superspeciality eye hospital |
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Name:
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Rahul Pandey
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Address:
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Nethradhama Superspeciality eye hospital, 256/14, Jayanagar 7th block, Bangalore. 256/14, Jayanagar 7th block, Bangalore 560082.
560082
Chandigarh, KARNATAKA
India |
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Telephone:
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9731809663 |
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Email:
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drrahulp2012@gmail.com |
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Affiliation:
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Nethradhama Superspeciality eye hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patient age 18 to 45
2. Stable refraction for at least two years
3. Lack of patient satisfaction with the correction provided by spectacles or contact lenses
4. ACD (measured from the endothelium to the crystalline lens) more than 3.0mm
5. Mesopic pupil size less than 5.0mm
6. Endothelial cell density (ECD) more than 2500/mm2
7. Normal iris and pupil configuration
8. No history of glaucoma and retinal detachment, retinal tear or hole.
Exclusion criteria: 1. Patients who had a simultaneous or consecutive additional refractive surgical procedure.
2. Patient having any intra-operative complications.
3. Corneal degenerations and opacities
4. History of glaucoma or retinal detachment, macular degeneration or retinopathy, neuro-ophthalmic diseases.
5. History of ocular inflammation.
6. Previous intraocular or refractive surgery
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Healthy individuals with short sight opting for refractive procedure.
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Primary Outcome(s)
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To study the incidence and factors responsible for ICL explantation following uneventful surgery.Timepoint: Postoperative Day 1, 15 then every 3 months.
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Secondary Outcome(s)
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To study visual outcome after icl explantation.Timepoint: Postoperative day 1, 15th day and every 3 months.
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Source(s) of Monetary Support
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Nethradhama Superspeciality eye hospital, 256/14, Jayanagar 7th block, Bangalore.
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Ethics review
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Status: Approved
Approval date: 04/03/2015
Contact:
Nethradhama superspeciality eye hospital institutional ethics committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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