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Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification

NCT ID: NCT04452279

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-08-15

Brief Summary

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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

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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

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Ocular Surface Disease Glaucoma, Open-Angle

Keywords

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ocular surface dry eye medication quality of life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ocular Surface Disease post-stenting

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.

Group Type EXPERIMENTAL

iStent or iStent inject implantation with concomitant cataract surgery

Intervention Type DEVICE

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).

Interventions

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iStent or iStent inject implantation with concomitant cataract surgery

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).

Intervention Type DEVICE

Other Intervention Names

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iStent or iStent inject

Eligibility Criteria

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Inclusion Criteria

1. Mild to moderate primary open-angle glaucoma
2. Currently treated with ocular hypotensive medication
3. Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
4. Subject scheduled to undergo cataract surgery in combination with one trabecular meshwork bypass stent
5. 22 years of age or older
6. Able and willing to attend scheduled follow-up exams for three months postoperatively
7. Able and willing to provide written informed consent on the IRB approved Informed Consent Form
8. Successful, uncomplicated cataract surgery
9. OSDI of 8 or more

Exclusion Criteria

* 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:

1. Cataract surgery
2. Stent implantation
3. 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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vance Thompson Vision

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Schweitzer, OD, FAAO

Role: PRINCIPAL_INVESTIGATOR

Vance Thompson Vision

Locations

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Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32789800 (View on PubMed)

Other Identifiers

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The OSD iStent Study

Identifier Type: -

Identifier Source: org_study_id