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

Glaucoma, Open-Angle Clinical Trial

Official title:

Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452279
• Other study ID #: The OSD iStent Study
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Surface Disease

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