Interval Intraocular Pressure in Intravitreal Injection Study (IIII)

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

Study Overview

• Status: Completed
• Conditions: Glaucoma; Intraocular Pressure
• Intervention / Treatment: Drug: Timolol; Drug: Travatan; Drug: Hypromellose

Detailed Description

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:

1. 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

2. Day 1 follow-up visit

   • IOP via iCare (sitting)
   • Slitlamp examination, document inflammation or complications if any

3. 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • HKSDS Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; control (hypromellose), then Timolol, then Travatan	Drug: Timolol; Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production; Drug: Travatan; Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow; Drug: Hypromellose; Placebo eye drop, lubricant
Active Comparator: Group 2; Timolol, then Travatan, Hypromellose	Drug: Timolol; Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production; Drug: Travatan; Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow; Drug: Hypromellose; Placebo eye drop, lubricant
Active Comparator: Group 3; Travatan, then Hypromellose, Timolol	Drug: Timolol; Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production; Drug: Travatan; Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow; Drug: Hypromellose; Placebo eye drop, lubricant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP effect of prophylactic IOP lowering eye drops over multiple time points	IOP in mmHg	From baseline to 30 minutes after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP effect of intravitreal injection	IOP in mmHg	From baseline to 30 minutes after injection
IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities	IOP in mmHg	From baseline to 30 minutes after injection
Inflammation to types of anti VEGF	presence of inflammation	1 week post injection

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Travoprost
• Other Study ID Numbers: IIII

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No