NCT07605260

Brief Summary

Local data regarding the effectiveness and safety of mannitol has been scarce. Therefore, the current study was planned, aiming to compare the change in mean anterior chamber depth and intraocular pressure (IOP) and to determine the frequencies of perioperative complications during cataract surgery in groups receiving mannitol versus placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in the intraocular pressure

    The change in the intraocular pressure, measured in mmHg, was noted at post-intervention and compared to the baseline.

    45 minutes

  • Change in the anterior chamber depth

    The change in the anterior chamber depth, measured in mm, was noted at post-intervention and compared to the baseline.

    45 minutes

Study Arms (2)

Group-A

EXPERIMENTAL

After employing standard protocol for dilatation, intravenous mannitol at 1g/kg over a period of 30 minutes was administered to the patients.

Drug: Mannitol

Group-B

PLACEBO COMPARATOR

After employing standard protocol for dilatation, patients were given a placebo.

Drug: Placebo

Interventions

After employing standard protocol for dilatation, intravenous mannitol at 1g/kg over a period of 30 minutes was administered to the patients.

Group-A

After employing standard protocol for dilatation, patients were given a placebo.

Group-B

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of any gender
  • Aged 30-80 years
  • Undergoing cataract surgery

You may not qualify if:

  • Patients with glaucoma, uveitis, or corneal pathology
  • With trauma
  • Previously had surgery
  • With exfoliation syndrome
  • Had iridotomies
  • Had use of sympathetic α1 antagonist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Air Force (PAF) hospital

Islamabad, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Cataract

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Muhammad Irtiza

    Pakistan Air Force (PAF) Hospital Islamabad

    PRINCIPAL INVESTIGATOR
  • Muhammad Azam, FCPS

    Pakistan Air Force (PAF) Hospital Islamabad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start

September 1, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations