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

• Sponsor: Vance Thompson Vision (Other)
• Overall Status: Completed
• CT.gov ID: NCT04452279
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arm: 1
• Actual Duration (Months): 15.5
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Ocular Surface Disease; Glaucoma, Open-Angle	Device: iStent or iStent inject implantation with concomitant cataract surgery	N/A

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

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Aug 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in mean OSDI score [3 months]

   Difference between preoperative and Month 3 mean OSDI score

2. Change in mean conjunctival hyperemia score [3 months]

   Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia

3. Change in mean corneal/conjunctival staining score [3 months]

   Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia

4. Change in mean fluorescein tear break-up time (FTBUT) [3 months]

   Difference between preoperative and Month 3 mean FTBUT in seconds

Secondary Outcome Measures

1. IOP change [3 months]

   Difference between preoperative and Month 3 mean IOP in mmHg

2. Medication change [3 months]

   Difference between preoperative and Month 3 mean number of glaucoma medications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vance Thompson Vision	Sioux Falls	South Dakota	United States	57108

Sponsors and Collaborators

• Vance Thompson Vision

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vance Thompson Vision
• ClinicalTrials.gov Identifier: NCT04452279
• Other Study ID Numbers: The OSD iStent Study
• First Posted: Jun 30, 2020
• Last Update Posted: Jun 30, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Vance Thompson Vision: ocular surface; dry eye; medication; quality of life
• Additional relevant MeSH terms: Glaucoma, Open-Angle

Study Results

No Results Posted as of Jun 30, 2020