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

Overview

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).

Full Title of Study: “Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2019

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).

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • IOP change
    • Time Frame: 3 months
    • Difference between preoperative and Month 3 mean IOP in mmHg
  • Medication change
    • Time Frame: 3 months
    • Difference between preoperative and Month 3 mean number of glaucoma medications

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vance Thompson Vision
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Justin Schweitzer, OD, FAAO, Principal Investigator, Vance Thompson Vision

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