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

Not Applicable

Completed

• Conditions: Ocular Surface Disease; Glaucoma, Open-Angle
• Interventions: Device: iStent or iStent inject implantation with concomitant cataract surgery

• Registration Number: NCT04452279
• Lead Sponsor: Vance Thompson Vision

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).

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 Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-08-15
• Status Verified: 2020-06
• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-28
• Last Update Submitted: 2020-06-28
• Study First Posted: 2020-06-30
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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:

  2. Cataract surgery

  3. Stent implantation

  4. 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ocular Surface Disease post-stenting	iStent or iStent inject implantation with concomitant cataract surgery	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
IOP change	3 months	Difference between preoperative and Month 3 mean IOP in mmHg
Medication change	3 months	Difference between preoperative and Month 3 mean number of glaucoma medications

Trial Locations

Locations (1)

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States