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Trial registered on ANZCTR


Registration number
ACTRN12624001457538
Ethics application status
Approved
Date submitted
3/10/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of intracameral dexamethasone plus moxifloxacin versus moxifloxacin alone after phacoemulsification in patients with age-related cataracts: A single-blinded randomized clinical trial
Scientific title
Efficacy and safety of intracameral dexamethasone plus moxifloxacin versus moxifloxacin alone after phacoemulsification in patients with age-related cataracts: A single-blinded randomized clinical trial
Secondary ID [1] 313011 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age related cataract 335673 0
Phacoemulsification 335674 0
Condition category
Condition code
Eye 331945 331945 0 0
Diseases / disorders of the eye
Surgery 332232 332232 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After establishing the standard anesthesia, Phacoemulsification with foldable posterior chamber intraocular lens will be performed by a single Ophthalmic surgeon. At the end of surgery after securing a stable and formed Anterior Chamber (AC), intracameral injection of Dexamethasone Sodium Phosphate (Decadron, Searle) at 0.4mg/0.1ml mixed with 0.5mg/0.1ml in of 0.5% preservative free moxifloxacin (Vigamox, Alcon Laboratories) through 1cc syringe with viscoelastic cannula will be injected through the side port, with in less than a minute. The eyelid retractor will be removed and 1 drop of (0.05ml of 5% same Moxifloxacin will be instilled in conjunctival cul-de- sac. After surgery ,the record of intervention will be secured with the ID of the patients in Hospital Management Information System(HMIS) for follow up on 1st ,10th and 40th post operative day.
Intervention code [1] 329680 0
Treatment: Drugs
Comparator / control treatment
After establishing the standard anesthesia, Phacoemulsification with foldable posterior chamber intraocular lens will be performed. At the end of surgery after securing a stable and formed AC, intracameral injection of 0.5mg/0.1ml in of 0.5% preservative free moxifloxacin (Vigamox, Alcon Laboratories) through 1cc syringe with viscoelastic cannula will be injected through the side port. The eyelid retractor will be removed and 1 drop of (0.05ml of 5%) same Moxifloxacin will be instilled in conjunctival cul -de- sac.
Control group
Active

Outcomes
Primary outcome [1] 339551 0
Change in the severity of postoperative inflammation
Timepoint [1] 339551 0
1st Postoperative day,10th and 40th postoperative day.
Primary outcome [2] 339552 0
presence of Endophthalmitis
Timepoint [2] 339552 0
1st ,10th and 40th postoperative day
Secondary outcome [1] 440408 0
Status of intra ocular pressure
Timepoint [1] 440408 0
1st,10th and 40th post operative day

Eligibility
Key inclusion criteria
All those patients of both gender, ethnicities and geographical location ,with age related cataracts who have undergone Phacoemulsification with out any per operative complications and with posterior chamber intraocular lens will be included in this study.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with traumatic and complicated cataracts, previous intraocular surgeries will be excluded from the study. Those patients with history of steroid responsive glaucoma will also be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The group assignments will be based on sequentially generated numbered in closed envelopes distributed by the PGR after enrollment the participants and assigning them to intervention and control groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There will be two groups of patients based on sample size, randomly allocated, using random sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment outside Australia
Country [1] 26612 0
Pakistan
State/province [1] 26612 0
Khyber Pukhtoon Khowa

Funding & Sponsors
Funding source category [1] 317450 0
Hospital
Name [1] 317450 0
medical Teaching Institute ,Lady Reading Hospital
Country [1] 317450 0
Pakistan
Primary sponsor type
Hospital
Name
Sihat Sahulat Card ,Lady Reading Hospital
Address
Country
Pakistan
Secondary sponsor category [1] 319740 0
None
Name [1] 319740 0
Address [1] 319740 0
Country [1] 319740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316166 0
Lady Reading Hospital,Medical Teaching Institututional review board (IRB)
Ethics committee address [1] 316166 0
Ethics committee country [1] 316166 0
Pakistan
Date submitted for ethics approval [1] 316166 0
07/10/2024
Approval date [1] 316166 0
06/11/2024
Ethics approval number [1] 316166 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137002 0
Dr Nuzhat Rahil
Address 137002 0
Lady Reading Hospital ,Soekarna Road ,PTCL Colony ,Peshawar .Khyber Pukhtoon Khowa.25000
Country 137002 0
Pakistan
Phone 137002 0
+92919211430
Fax 137002 0
Email 137002 0
nuzhat.rahil@lrh.edu.pk
Contact person for public queries
Name 137003 0
Nuzhat Rahil
Address 137003 0
Lady Reading Hospital ,Soekarna Road ,PTCL Colony ,Peshawar .Khyber Pukhtoon Khowa.25000
Country 137003 0
Pakistan
Phone 137003 0
+92919211430
Fax 137003 0
Email 137003 0
nuzhat.rahil@lrh.edu.pk
Contact person for scientific queries
Name 137004 0
Nuzhat Rahil
Address 137004 0
Lady Reading Hospital ,Soekarna Road ,PTCL Colony ,Peshawar .Khyber Pukhtoon Khowa.25000
Country 137004 0
Pakistan
Phone 137004 0
+92919211430
Fax 137004 0
Email 137004 0
nuzhat.rahil@lrh.edu.pk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24241Informed consent form    388486-(Uploaded-03-10-2024-20-13-28)-Consent _1 (1).pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.