## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** The OSD iStent Study
#### Organization
**Class:** OTHER
**Full Name:** Vance Thompson Vision
### Status Module
#### Completion Date
**Date:** 2019-08-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-30

**Type:** ACTUAL

**Last Update Submit Date:** 2020-06-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2018-05-01

**Type:** ACTUAL

**Status Verified Date:** 2020-06

#### Study First Post Date
**Date:** 2020-06-30
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-24
**Study First Submit QC Date:** 2020-06-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Vance Thompson Vision

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Ocular Surface Disease

- Glaucoma, Open-Angle

**Keywords:**

- ocular surface

- dry eye

- medication

- quality of life

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 47

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: iStent or iStent inject implantation with concomitant cataract surgery

**Label:** Ocular Surface Disease post-stenting

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ocular Surface Disease post-stenting

**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).

**Name:** iStent or iStent inject implantation with concomitant cataract surgery

**Other Names:**

- iStent or iStent inject

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Difference between preoperative and Month 3 mean OSDI score

**Measure:** Change in mean OSDI score

**Time Frame:** 3 months

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

**Measure:** Change in mean conjunctival hyperemia score

**Time Frame:** 3 months

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

**Measure:** Change in mean corneal/conjunctival staining score

**Time Frame:** 3 months

**Description:** Difference between preoperative and Month 3 mean FTBUT in seconds

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

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** Difference between preoperative and Month 3 mean IOP in mmHg

**Measure:** IOP change

**Time Frame:** 3 months

**Description:** Difference between preoperative and Month 3 mean number of glaucoma medications

**Measure:** Medication change

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 22 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sioux Falls

**Country:** United States

**Facility:** Vance Thompson Vision

**State:** South Dakota

**Zip:** 57108

#### Overall Officials

**Official 1:**

**Affiliation:** Vance Thompson Vision

**Name:** Justin Schweitzer, OD, FAAO

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 32789800

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005901

- Term: Glaucoma

- ID: D000009798

- Term: Ocular Hypertension

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M5638

- Name: Cataract

- Relevance: LOW

- As Found: Unknown

- ID: M18040

- Name: Dry Eye Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: LOW

- As Found: Unknown

- ID: M9013

- Name: Glaucoma

- Relevance: LOW

- As Found: Unknown

- ID: M9014

- Name: Glaucoma, Open-Angle

- Relevance: HIGH

- As Found: Glaucoma, Open-Angle

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M12731

- Name: Ocular Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005902

- Term: Glaucoma, Open-Angle

### Misc Info Module

- Version Holder: 2024-05-24
