IolNCT02618018
Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
A study testing AT TORBI 709M in people with Iol and Astigmatism, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic toric IOL in cataract surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Iol, Astigmatism
- What is being tested?
- AT TORBI 709M
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- senile cataract
- patients' age of 21 years or older
- preoperative regular corneal astigmatism between 1.00 D and 6.00 D
Who cannot join
- pregnant, lactating women
- presence of other ocular diseases which affect stability of lens capsule
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 110-744
Mee Kum Kim, MD, PhD, 82-10-6277-0798, kmk9@snu.ac.kr
Yu Jeong Kim, MD, 82-10-2559-1377, 21cnasa@naver.com
About this study
Official title: An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic toric IOL in cataract surgery.
Read the detailed description
Inclusion criteria
- senile cataract
- patients' age of 21 years or older
- preoperative regular corneal astigmatism between 1.00 D and 6.00 D
Exclusion criteria
- pregnant, lactating women
- presence of other ocular diseases which affect stability of lens capsule
Primary outcome : efficacy index (visual acuity, refractive results Secondary outcome : rotational stability, endothelial cell count, cornea thickness
- Conditions
- Iol, Astigmatism
- Being tested
- AT TORBI 709M
- Keywords
- astigmatism, toric intraocular lens
- Medical subject headings
- Intraocular Lymphoma, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT TORBI 709MProcedure or surgery
Cataract surgery with AT TORBI 709M 4-haptic toric IOL
| Study group | Role | What they receive |
|---|---|---|
| intraocular lens | Experimental | AT TORBI 709M toric intraocular lens Receives: Procedure: AT TORBI 709M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity, refractive results
uncorrected distance visual acuity (UCDVA) and best corrected distance visual acuity (BCDVA) measured using logarithm of the minimum angle of resolution (logMAR) refractive results measured by keratometry
Measured: 3 months
Secondary outcomes (3)
Rotational stability
Photographic evaluation of IOL rotation using slit-lamp digital photographs at each postoperative visit, and determine changes in the lens axis between visits.
Measured: 3 months
Endothelial cell count
measured by specular microscopy
Measured: 3 months
Cornea thickness
measured by ultrasound pachymetry
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startSep 2015
- 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.
- Other trials for IolStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mee Kum Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618018
- Sponsor's protocol ID
- AT TORBI 709M toric IOL
- Status last verified
- Nov 2015
- First submitted
- 20 May 2015
- Last updated
- 1 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
- ClinicalTrials.gov ID
- NCT02618018
- Acronym / sponsor ID
- AT TORBI 709M toric IOL
- Conditions
- Iol, Astigmatism
- Keywords
- astigmatism, toric intraocular lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Dec 2015 (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 purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic toric IOL in cataract surgery.
Detailed description
Inclusion criteria
- senile cataract
- patients' age of 21 years or older
- preoperative regular corneal astigmatism between 1.00 D and 6.00 D
Exclusion criteria
- pregnant, lactating women
- presence of other ocular diseases which affect stability of lens capsule
Primary outcome : efficacy index (visual acuity, refractive results Secondary outcome : rotational stability, endothelial cell count, cornea thickness
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraocular lens | Experimental | Procedure: AT TORBI 709MAT TORBI 709M toric intraocular lens |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- senile cataract
- patients' age of 21 years or older
- preoperative regular corneal astigmatism between 1.00 D and 6.00 D
Key exclusion criteria (2 listed)
- pregnant, lactating women
- presence of other ocular diseases which affect stability of lens capsule
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 |
|---|---|---|
| AT TORBI 709MCataract surgery with AT TORBI 709M 4-haptic toric IOL | Procedure or surgery | intraocular lens |
Primary outcome
Visual acuity, refractive results
Time frame: 3 months
uncorrected distance visual acuity (UCDVA) and best corrected distance visual acuity (BCDVA) measured using logarithm of the minimum angle of resolution (logMAR) refractive results measured by keratometry
3 secondary outcomes
Rotational stability
Time frame: 3 months
Endothelial cell count
Time frame: 3 months
Cornea thickness
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2015.
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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.
Mee Kum Kim, MD, PhD principal investigator
Seoul National University 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 AT TORBI 709M in people with Iol and Astigmatism, run by Seoul National University Hospital at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 1 Dec 2015. 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 South Korea. 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 Mee Kum Kim, MD, PhD (82-10-6277-0798, kmk9@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity, refractive results (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2015.