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

NCT04452279 | Completed FDA Device

• 1 other identifier: The OSD iStent Study
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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).

Conditions

Ocular Surface Disease; Glaucoma, Open-Angle

Keywords

ocular surface; dry eye; medication; quality of life

Outcome Measures

Primary Outcomes (4)

• Change in mean OSDI score

  Difference between preoperative and Month 3 mean OSDI score

  3 months

• Change in mean conjunctival hyperemia score

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

  3 months

• Change in mean corneal/conjunctival staining score

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

  3 months

• Change in mean fluorescein tear break-up time (FTBUT)

  Difference between preoperative and Month 3 mean FTBUT in seconds

  3 months

Secondary Outcomes (2)

• IOP change

  3 months

• Medication change

  3 months

Study Arms (1)

Ocular Surface Disease post-stenting

EXPERIMENTAL

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

Interventions

iStent or iStent inject implantation with concomitant cataract surgery DEVICE

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).

Also known as: iStent or iStent inject

Ocular Surface Disease post-stenting

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate primary open-angle glaucoma
• Currently treated with ocular hypotensive medication
• Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
• Subject scheduled to undergo cataract surgery in combination with one trabecular meshwork bypass stent
• years of age or older
• Able and willing to attend scheduled follow-up exams for three months postoperatively
• Able and willing to provide written informed consent on the IRB approved Informed Consent Form
• Successful, uncomplicated cataract surgery
• OSDI of 8 or more

You may not qualify if:

• \. 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:
• Cataract surgery
• Stent implantation
• 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

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Related Publications (1)

• Schweitzer JA, Hauser WH, Ibach M, Baartman B, Gollamudi SR, Crothers AW, Linn JE, Berdahl JP. Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification. Ophthalmol Ther. 2020 Dec;9(4):941-953. doi: 10.1007/s40123-020-00290-6. Epub 2020 Aug 13.

  PMID: 32789800 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Justin Schweitzer, OD, FAAO

  Vance Thompson Vision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 30, 2020
• Study Start: May 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: August 15, 2019
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)