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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04452279
Other study ID # The OSD iStent Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date August 15, 2019

Study information

Verified date June 2020
Source Vance Thompson Vision
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date August 15, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
United States Vance Thompson Vision Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
Vance Thompson Vision

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mean OSDI score Difference between preoperative and Month 3 mean OSDI score 3 months
Primary Change in mean conjunctival hyperemia score Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia 3 months
Primary Change in mean corneal/conjunctival staining score Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia 3 months
Primary Change in mean fluorescein tear break-up time (FTBUT) Difference between preoperative and Month 3 mean FTBUT in seconds 3 months
Secondary IOP change Difference between preoperative and Month 3 mean IOP in mmHg 3 months
Secondary Medication change Difference between preoperative and Month 3 mean number of glaucoma medications 3 months
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