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

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).

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle; Ocular Surface Disease
• Intervention / Treatment: Device: iStent or iStent inject implantation with concomitant cataract surgery

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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).; Other Names: iStent or iStent inject

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean OSDI score	Difference between preoperative and Month 3 mean OSDI score	3 months
Change in mean conjunctival hyperemia score	Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia	3 months
Change in mean corneal/conjunctival staining score	Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia	3 months
Change in mean fluorescein tear break-up time (FTBUT)	Difference between preoperative and Month 3 mean FTBUT in seconds	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP change	Difference between preoperative and Month 3 mean IOP in mmHg	3 months
Medication change	Difference between preoperative and Month 3 mean number of glaucoma medications	3 months

Collaborators and Investigators

• Sponsor: Vance Thompson Vision
• Investigators: Principal Investigator: Justin Schweitzer, OD, FAAO, Vance Thompson Vision

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): August 15, 2019

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 28, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; medication; dry eye; ocular surface
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: The OSD iStent Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes