Interval Intraocular Pressure in Intravitreal Injection Study (IIII)

April 27, 2021 updated by: The University of Hong Kong

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From baseline to 30 minutes after injection
IOP in mmHg
From baseline to 30 minutes after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP effect of intravitreal injection
Time Frame: From baseline to 30 minutes after 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
Time Frame: From baseline to 30 minutes after injection
IOP in mmHg
From baseline to 30 minutes after injection
Inflammation to types of anti VEGF
Time Frame: 1 week post injection
presence of inflammation
1 week post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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