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Completed

NCT Number: NCT04452279

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

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).

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: iStent or iStent inject

Primary outcomes

  1. Change in mean OSDI score

    Time frame: 3 months

    Difference between preoperative and Month 3 mean OSDI score

  2. Change in mean conjunctival hyperemia score

    Time frame: 3 months

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

  3. Change in mean corneal/conjunctival staining score

    Time frame: 3 months

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

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

    Time frame: 3 months

    Difference between preoperative and Month 3 mean FTBUT in seconds

Secondary outcomes

  1. IOP change

    Time frame: 3 months

    Difference between preoperative and Month 3 mean IOP in mmHg

  2. Medication change

    Time frame: 3 months

    Difference between preoperative and Month 3 mean number of glaucoma medications

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 30, 2020
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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