CataractNCT02328157
Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.
A study testing Vitrectomy with cataract surgery and toric IOL and Vitrectomy with cataract surgery and common IOL in people with Cataract and Epiretinal Membrane, run by Kagawa University at 1 site in Japan.
Trial summary
Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative corneal astigmatism. Symptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival sutureless vitrectomy, resulting in good visual recovery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract, Epiretinal Membrane, Corneal Astigmatism
- What is being tested?
- Vitrectomy with cataract surgery and toric IOL and Vitrectomy with cataract surgery and common IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2015to Oct 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preoperative corneal cylinder of more than 0.75 diopter
- Symptomatic idiopathic epiretinal membrane
- Symptomatic cataract
Who cannot join
- Severe media opacity other cataract
- Eyes with other retinal disease, such as diabetic retinopathy, retinal vein occlusion, rhegmatogenous retinal detachment
Trial locations and contacts
1 site in 1 country.
About this study
Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative corneal astigmatism.
Symptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival sutureless vitrectomy, resulting in good visual recovery. So far, however, limited information is available on the the stability of axis rotation, astigmatism correction, and improvement in uncorrected distance visual acuity, using astigmatism-correcting IOL in a 25-gauge transconjunctival sutureless vitrectomy combined with cataract surgery. In the current study, eyes with a preoperative corneal cylinder of more than 0.75 diopter had a triple procedure for idiopathic ERM using a toric IOL. Outcome measures will be the amount of IOL axis rotation, uncorrected visual acuity, corrected distance visual acuity, and corneal and refractive astigmatism up to 6 months postoperatively. We are expecting to show that postoperative IOL axis stability is similar to that reported for cataract surgery alone in vitrectomy (triple procedure) for idiopathic ERM with a toric IOL.
- Conditions
- Cataract, Epiretinal Membrane, Corneal Astigmatism
- Being tested
- Vitrectomy with cataract surgery and toric IOL, Vitrectomy with cataract surgery and common IOL
- Medical subject headings
- Cataract, Epiretinal Membrane, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy with cataract surgery and toric IOLDevice
Vitrectomy with cataract surgery and common IOLDevice
| Study group | Role | What they receive |
|---|---|---|
| Cataract with ERM and astigmatism | Experimental | Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter. Receives: Device: Vitrectomy with cataract surgery and toric IOL; Device: Vitrectomy with cataract surgery and common IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of IOL axis rotation from the end of surgery
Measured: Six months after the inplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kagawa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akitaka Tsujikawa, Kagawa University
- Investigators
- AKITAKA TSUJIKAWA, MD, Principal investigator, Kagawa Univerisity Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328157
- Sponsor's protocol ID
- H26-061
- Status last verified
- Mar 2018
- First submitted
- 13 Dec 2014
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.
- ClinicalTrials.gov ID
- NCT02328157
- Acronym / sponsor ID
- H26-061
- Conditions
- Cataract, Epiretinal Membrane, Corneal Astigmatism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kagawa UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 31 Dec 2014 (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.
Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative corneal astigmatism.
Symptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival sutureless vitrectomy, resulting in good visual recovery. So far, however, limited information is available on the the stability of axis rotation, astigmatism correction, and improvement in uncorrected distance visual acuity, using astigmatism-correcting IOL in a 25-gauge transconjunctival sutureless vitrectomy combined with cataract surgery. In the current study, eyes with a preoperative corneal cylinder of more than 0.75 diopter had a triple procedure for idiopathic ERM using a toric IOL. Outcome measures will be the amount of IOL axis rotation, uncorrected visual acuity, corrected distance visual acuity, and corneal and refractive astigmatism up to 6 months postoperatively. We are expecting to show that postoperative IOL axis stability is similar to that reported for cataract surgery alone in vitrectomy (triple procedure) for idiopathic ERM with a toric IOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract with ERM and astigmatism | Experimental | Device: Vitrectomy with cataract surgery and toric IOL, Device: Vitrectomy with cataract surgery and common IOLEyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preoperative corneal cylinder of more than 0.75 diopter
- Symptomatic idiopathic epiretinal membrane
- Symptomatic cataract
Key exclusion criteria (2 listed)
- Severe media opacity other cataract
- Eyes with other retinal disease, such as diabetic retinopathy, retinal vein occlusion, rhegmatogenous retinal detachment
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 |
|---|---|---|
| Vitrectomy with cataract surgery and toric IOL | Device | Cataract with ERM and astigmatism |
| Vitrectomy with cataract surgery and common IOL | Device | Cataract with ERM and astigmatism |
Primary outcome
The degree of IOL axis rotation from the end of surgery
Time frame: Six months after the inplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
AKITAKA TSUJIKAWA, MD principal investigator
Kagawa Univerisity Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy with cataract surgery and toric IOL and Vitrectomy with cataract surgery and common IOL in people with Cataract and Epiretinal Membrane, run by Kagawa University at 1 site in Japan.
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 7 Mar 2018. 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 Japan. 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?
The degree of IOL axis rotation from the end of surgery (time frame: Six months after the inplantation). 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 7 Mar 2018.