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

Primary Purpose

Ocular Surface Disease, Glaucoma, Open-Angle

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

iStent or iStent inject implantation with concomitant cataract surgery

About this trial

This is an interventional treatment trial for Ocular Surface Disease focused on measuring ocular surface, dry eye, medication, quality of life

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
22 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

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

Sites / Locations

Vance Thompson Vision

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ocular Surface Disease post-stenting

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in mean OSDI score

Difference between preoperative and Month 3 mean OSDI score

Change in mean conjunctival hyperemia score

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

Change in mean corneal/conjunctival staining score

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

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

Difference between preoperative and Month 3 mean FTBUT in seconds

Secondary Outcome Measures

IOP change

Difference between preoperative and Month 3 mean IOP in mmHg

Medication change

Difference between preoperative and Month 3 mean number of glaucoma medications

Full Information

NCT ID

NCT04452279

First Posted

June 24, 2020

Last Updated

June 28, 2020

Sponsor

Vance Thompson Vision

1. Study Identification

Unique Protocol Identification Number

NCT04452279

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

March 1, 2019 (Actual)

Study Completion Date

August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vance Thompson Vision

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Surface Disease, Glaucoma, Open-Angle

Keywords

ocular surface, dry eye, medication, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ocular Surface Disease post-stenting

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

iStent or iStent inject implantation with concomitant cataract surgery

Other Intervention Name(s)

iStent or iStent inject

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in mean OSDI score

Description

Difference between preoperative and Month 3 mean OSDI score

Time Frame

3 months

Title

Change in mean conjunctival hyperemia score

Description

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

Time Frame

3 months

Title

Change in mean corneal/conjunctival staining score

Description

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

Time Frame

3 months

Title

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

Description

Difference between preoperative and Month 3 mean FTBUT in seconds

Time Frame

3 months

Secondary Outcome Measure Information:

Title

IOP change

Description

Difference between preoperative and Month 3 mean IOP in mmHg

Time Frame

3 months

Title

Medication change

Description

Difference between preoperative and Month 3 mean number of glaucoma medications

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 22 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 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Justin Schweitzer, OD, FAAO

Organizational Affiliation

Vance Thompson Vision

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vance Thompson Vision

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57108

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32789800

Citation

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.

Results Reference

derived

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

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