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Completed

NCT Number: NCT04868175

Interval Intraocular Pressure in Intravitreal Injection Study

This is a prospective study of IOP in Intravitreal injections to evaluate:

1. IOP effect of intravitreal injection 2. IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods 3. IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HKSDS Program

Hong Kong, 000000

About this study

Study design: A prospective study Sample size: 60 patients (180 readings) Recruitment: Patients will be recruited at the intravitreal injection clinic in Grantham Hospital.

Randomization:

Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol

There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly.

Injection doctors masked to treatments given.

Study visits:

  • Injection visit
  • Record the anti-VFGF injection to be given
  • Macula disease involved
  • Record no. of previous injections
  • Prophylactic eye drops will be given according to treatment group 1 hour prior injection
  • IOP immediately before injection (without speculum while sitting on table)
  • IOP immediately after injection (without speculum while sitting on table)
  • IOP 30 minutes after injection via iCare
  • Slitlamp examination, document inflammation or complications if any
  • Day 1 follow-up visit
  • IOP via iCare (sitting)
  • Slitlamp examination, document inflammation or complications if any
  • Week 1 follow-up visit
  • IOP via iCare (sitting)
  • Slitlamp examination, document inflammation or complications if any Visit a, b and c will be repeated for 2nd and 3rd injections.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • AMD patients requiring multiple intravitreal injections (Eylea or Lucentis), not necessarily 3 month loading.
  • Age >50
  • Chinese patients with ability to read Chinese ICF

Exclusion criteria

  • Known glaucoma
  • Corneal disease e.g. corneal scarring or opacity preventing fundal view
  • On steroid or anti glaucoma eye drops
  • Prior vitrectomy or glaucoma surgery
  • Recent intraocular surgery i.e. cataracts surgery
  • Pseudophakic with anterior chamber IOL
  • History of ocular inflammatory disease e.g. uveitis
  • Previous laser iridotomy
  • Recent intravitreal injection of steroid
  • Inability for regular follow-up

Treatment and study plan

Timolol

Drug

Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production

TRAVATAN

Drug

Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow

Hypromellose

Drug

Placebo eye drop, lubricant

Primary outcomes

  1. IOP effect of prophylactic IOP lowering eye drops over multiple time points

    Time frame: From baseline to 30 minutes after injection

    IOP in mmHg

Secondary outcomes

  1. IOP effect of intravitreal injection

    Time frame: From baseline to 30 minutes after injection

    IOP in mmHg

  2. IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities

    Time frame: From baseline to 30 minutes after injection

    IOP in mmHg

  3. Inflammation to types of anti VEGF

    Time frame: 1 week post injection

    presence of inflammation

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study

Acronym: IIII

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Apr 30, 2021

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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