CapsulorhexisNCT02315456
Evaluation of Centration of Intraocular Lens With Two Settings for Capsulorhexis With Femtosecond Laser
A study testing capsulorhexis in people with Capsulorhexis, run by Northwestern University at 1 site in United States.
Trial summary
The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to… Read more about this study
- Who is it for?
- Ages 45 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Capsulorhexis
- What is being tested?
- capsulorhexis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 9 Aug 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 45 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with cataracts
- Same variety of IOL inserted in all eyes
Who cannot join
- Previous glaucoma or retinal surgery
- Pupil not dilating beyond 6mm
- Zonular weakness or pseudoexfoliation
- Extensive corneal scarring
- High refractive error: Myopia greater than 10D, Hyperopia greater than 5D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Evaluation of Centration of Intraocular Lens With Two Laser Settings for Capsulorhexis With Femtosecond Laser
The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.
Read the detailed description
50 consecutive eyes undergoing cataract surgery will be studied. 25 eyes will have scanned capsule centration and 25 will have pupil centration. Retroillumination slitlamp photographs will be taken 10-30 days after surgery with dilated pupils. The amount of capsule overlapping the IOL will be documented. The horizontal, vertical and symmetricity of overlap will be calculated.
Each group will have 20 eyes with an additional 5 eyes in each group to account for drop outs or poor quality images.
- Conditions
- Capsulorhexis
- Being tested
- capsulorhexis
- Keywords
- capsulorhexis, IOL centration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsulorhexisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Capsule centration | Other | Capsulorhexis made with capsule centration Receives: Procedure: capsulorhexis |
| Pupil centration | Other | Capsulorhexis made with pupil centration Receives: Procedure: capsulorhexis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL
The horizontal and vertical overlap will be calculated. Horizontal overlap= Overlap of the temporal half versus the nasal half Vertical overlap= overlap of the superior half versus the inferior half of the IOL.
Symmetricity of overlap= Horizontal overlap/vertical overlap
Measured: 10-30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion9 Aug 2016
- Study completion9 Aug 2016
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 CapsulorhexisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- OptiMedica Corporation
- Responsible party
- Principal investigator, Surendra Basti, Northwestern University
- Investigators
- Surendra Basti, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315456
- Sponsor's protocol ID
- 1234
- Status last verified
- Feb 2020
- First submitted
- 9 Dec 2014
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
de Castro A, Rosales P, Marcos S. Tilt and decentration of intraocular lenses in vivo from Purkinje and Scheimpflug imaging. Validation study. J Cataract Refract Surg. 2007 Mar;33(3):418-29. doi: 10.1016/j.jcrs.2006.10.054.
PubMed 17321392
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of Centration of Intraocular Lens With Two Laser Settings for Capsulorhexis With Femtosecond Laser
- ClinicalTrials.gov ID
- NCT02315456
- Acronym / sponsor ID
- 1234
- Conditions
- Capsulorhexis
- Keywords
- capsulorhexis, IOL centration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- OptiMedica Corporation
- Study start
- Dec 2014 (actual)
- Primary completion
- 9 Aug 2016 (actual)
- Study completion
- 9 Aug 2016 (actual)
- First posted
- 11 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.
The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.
Detailed description
50 consecutive eyes undergoing cataract surgery will be studied. 25 eyes will have scanned capsule centration and 25 will have pupil centration. Retroillumination slitlamp photographs will be taken 10-30 days after surgery with dilated pupils. The amount of capsule overlapping the IOL will be documented. The horizontal, vertical and symmetricity of overlap will be calculated.
Each group will have 20 eyes with an additional 5 eyes in each group to account for drop outs or poor quality images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsule centration | Other | Procedure: capsulorhexisCapsulorhexis made with capsule centration |
| Pupil centration | Other | Procedure: capsulorhexisCapsulorhexis made with pupil centration |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with cataracts
- Same variety of IOL inserted in all eyes
Key exclusion criteria (5 listed)
- Previous glaucoma or retinal surgery
- Pupil not dilating beyond 6mm
- Zonular weakness or pseudoexfoliation
- Extensive corneal scarring
- High refractive error: Myopia greater than 10D, Hyperopia greater than 5D
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 |
|---|---|---|
| capsulorhexis | Procedure or surgery | Capsule centration, Pupil centration |
Primary outcome
Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL
Time frame: 10-30 days post surgery
The horizontal and vertical overlap will be calculated. Horizontal overlap= Overlap of the temporal half versus the nasal half Vertical overlap= overlap of the superior half versus the inferior half of the IOL. Symmetricity of overlap= Horizontal overlap/vertical overlap
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 Feb 2020.
- Background: PubMed 17321392de Castro A, Rosales P, Marcos S. Tilt and decentration of intraocular lenses in vivo from Purkinje and Scheimpflug imaging. Validation study. J Cataract Refract Surg. 2007 Mar;33(3):418-29. doi: 10.1016/j.jcrs.2006.10.054.
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.
Surendra Basti, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capsulorhexis in people with Capsulorhexis, run by Northwestern University at 1 site in United States.
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 2 inclusion and 5 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 Feb 2020. 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 United States. 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?
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?
Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL (time frame: 10-30 days post surgery). 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 NCT02315456, 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 Feb 2020.