Ocular Surface DiseaseNCT04452279
Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification
A study testing iStent or iStent inject implantation with concomitant cataract surgery in people with Ocular Surface Disease and Glaucoma, Open-Angle, run by Vance Thompson Vision at 1 site in United States.
Trial summary
This prospective interventional single-arm trial evaluates measures changes in ocular surface disease parameters in eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who undergo phacoemulsification and trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Ocular Surface Disease, Glaucoma, Open-Angle
- What is being tested?
- iStent or iStent inject implantation with concomitant cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 15 Aug 2019
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate primary open-angle glaucoma
- Currently treated with ocular hypotensive medication
- Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
- Subject scheduled to undergo cataract surgery in combination with one trabecular meshwork bypass stent
- 22 years of age or older
- Able and willing to attend scheduled follow-up exams for three months postoperatively
Show all 9Show fewer
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
- Successful, uncomplicated cataract surgery
- OSDI of 8 or more
Who cannot join
- 1. Primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma 2. Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
- Cataract surgery
- Stent implantation
- Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits) 3. Fellow eye actively enrolled in this trial 4. Current participation in any study, or participation within 30 calendar days of screening exam 5. Unsuccessful, complicated cataract surgery 6. OSDI of 7 or less
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Official title: Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery
This prospective interventional single-arm trial evaluates measures changes in ocular surface disease parameters in eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who undergo phacoemulsification and trabecular micro-bypass stent(s) implantation (iStent or iStent inject).
Read the detailed description
This study enrolled eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who were scheduled to undergo phacoemulsification cataract extraction and trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Study participation entailed measurement of key ocular surface data through 3 months postoperative including Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), and conjunctival hyperemia (Efron Scale); these measures were collected alongside standard postoperative glaucoma evaluations such as number of glaucoma medications and intraocular pressure (IOP).
- Conditions
- Ocular Surface Disease, Glaucoma, Open-Angle
- Being tested
- iStent or iStent inject implantation with concomitant cataract surgery
- Keywords
- ocular surface, dry eye, medication, quality of life
- Medical subject headings
- Glaucoma, Open-Angle, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStent or iStent inject implantation with concomitant cataract surgeryDevice
Also called iStent or iStent inject
Standard phacoemulsification cataract surgery followed by ab interno implantation of either iStent or iStent inject trabecular micro-bypass stent(s). Preoperatively and at specified visits through 3 months postoperative, patients will complete evaluations of their ocular surface disease (specifically OSDI score, hyperemia, corneal/conjunctival staining, and tear break-up time).
| Study group | Role | What they receive |
|---|---|---|
| Ocular Surface Disease post-stenting | Experimental | Eyes will undergo phacoemulsification cataract surgery combined with iStent or iStent inject implantation according to standard clinical practice. From baseline through 3 months postoperatively, participants will complete subjective and objective assessments of ocular surface disease. Receives: Device: iStent or iStent inject implantation with concomitant cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean OSDI score
Difference between preoperative and Month 3 mean OSDI score
Measured: 3 months
Change in mean conjunctival hyperemia score
Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia
Measured: 3 months
Change in mean corneal/conjunctival staining score
Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia
Measured: 3 months
Change in mean fluorescein tear break-up time (FTBUT)
Difference between preoperative and Month 3 mean FTBUT in seconds
Measured: 3 months
Secondary outcomes (2)
IOP change
Difference between preoperative and Month 3 mean IOP in mmHg
Measured: 3 months
Medication change
Difference between preoperative and Month 3 mean number of glaucoma medications
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 posted30 Jun 2020
- Study start1 May 2018
- Primary completion1 Mar 2019
- Study completion15 Aug 2019
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 Ocular Surface DiseaseStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Schweitzer, OD, FAAO, Principal investigator, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452279
- Sponsor's protocol ID
- The OSD iStent Study
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schweitzer JA, Hauser WH, Ibach M, Baartman B, Gollamudi SR, Crothers AW, Linn JE, Berdahl JP. Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification. Ophthalmol Ther. 2020 Dec;9(4):941-953. doi: 10.1007/s40123-020-00290-6. Epub 2020 Aug 13.
PubMed 32789800
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery
- ClinicalTrials.gov ID
- NCT04452279
- Acronym / sponsor ID
- The OSD iStent Study
- Conditions
- Ocular Surface Disease, Glaucoma, Open-Angle
- Keywords
- ocular surface, dry eye, medication, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 30 Jun 2020 (actual)
- 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.
This prospective interventional single-arm trial evaluates measures changes in ocular surface disease parameters in eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who undergo phacoemulsification and trabecular micro-bypass stent(s) implantation (iStent or iStent inject).
Detailed description
This study enrolled eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who were scheduled to undergo phacoemulsification cataract extraction and trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Study participation entailed measurement of key ocular surface data through 3 months postoperative including Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), and conjunctival hyperemia (Efron Scale); these measures were collected alongside standard postoperative glaucoma evaluations such as number of glaucoma medications and intraocular pressure (IOP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocular Surface Disease post-stenting | Experimental | Device: iStent or iStent inject implantation with concomitant cataract surgeryEyes will undergo phacoemulsification cataract surgery combined with iStent or iStent inject implantation according to standard clinical practice. From baseline through 3 months postoperatively, participants will complete subjective and objective assessments of ocular surface disease. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Mild to moderate primary open-angle glaucoma
- Currently treated with ocular hypotensive medication
- Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
- Subject scheduled to undergo cataract surgery in combination with one trabecular meshwork bypass stent
- 22 years of age or older
Key exclusion criteria (4 listed)
- 1. Primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma 2. Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
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 |
|---|---|---|
| iStent or iStent inject implantation with concomitant cataract surgeryAlso: iStent or iStent injectStandard phacoemulsification cataract surgery followed by ab interno implantation of either iStent or iStent inject trabecular micro-bypass stent(s). Preoperatively and at specified visits through 3 months postoperative, patients will complete evaluations of their ocular surface disease (specifically OSDI score, hyperemia, corneal/conjunctival staining, and tear break-up time). | Device | Ocular Surface Disease post-stenting |
Primary outcome
Change in mean OSDI score
Time frame: 3 months
Difference between preoperative and Month 3 mean OSDI score
Change in mean conjunctival hyperemia score
Time frame: 3 months
Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia
Change in mean corneal/conjunctival staining score
Time frame: 3 months
Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia
Change in mean fluorescein tear break-up time (FTBUT)
Time frame: 3 months
Difference between preoperative and Month 3 mean FTBUT in seconds
2 secondary outcomes
IOP change
Time frame: 3 months
Medication change
Time frame: 3 months
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 30 Jun 2020.
- Derived from this study: PubMed 32789800Schweitzer JA, Hauser WH, Ibach M, Baartman B, Gollamudi SR, Crothers AW, Linn JE, Berdahl JP. Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification. Ophthalmol Ther. 2020 Dec;9(4):941-953. doi: 10.1007/s40123-020-00290-6. Epub 2020 Aug 13.
- Individual participant dataSharing planned: No
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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.
Justin Schweitzer, OD, FAAO principal investigator
Vance Thompson Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iStent or iStent inject implantation with concomitant cataract surgery in people with Ocular Surface Disease and Glaucoma, Open-Angle, run by Vance Thompson Vision 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 9 inclusion and 4 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 30 Jun 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?
Change in mean OSDI score (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT04452279, 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 30 Jun 2020.