Prophylactic Use of Timolol Maleate to Prevent Intraocular Pressure Elevation After Nd:YAG Laser Posterior Capsulotomy

NCT07729189 | Completed

• 1 other identifier: CIMS2
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated whether a single drop of 0.5% timolol maleate, administered before neodymium-doped yttrium aluminium garnet (Nd:YAG) laser posterior capsulotomy, reduced the rise in intraocular pressure compared with standard care alone. The study included adults aged 18-65 years who had developed posterior capsular opacification at least 3 months after cataract surgery and were scheduled to undergo Nd:YAG laser posterior capsulotomy. Participants were randomly assigned to receive either prophylactic topical timolol maleate or standard care without prophylactic timolol. Intraocular pressure was measured before the laser procedure and again 1 hour after the procedure by an ophthalmologist who was unaware of the assigned treatment. The study was based on the hypothesis that mean intraocular pressure 1 hour after posterior capsulotomy would be lower among participants who received prophylactic timolol maleate than among those who received standard care alone.

Conditions

Capsule Opacification; Ocular Hypertension

Keywords

Posterior Capsule Opacification; Timolol Maleate; Intraocular Pressure; Posterior Capsulotomy; Neodymium-Doped Yttrium Aluminum Garnet Laser

Outcome Measures

Primary Outcomes (1)

• Mean Intraocular Pressure 1 Hour After Nd:YAG Laser Posterior Capsulotomy

  Intraocular pressure was measured in millimetres of mercury using a Canon non-contact tonometer. The mean intraocular pressure measured 1 hour after Nd:YAG laser posterior capsulotomy was compared between participants who received one drop of 0.5% topical timolol maleate before the procedure and participants who received standard care without prophylactic timolol.

  1 hour after Nd:YAG laser posterior capsulotomy

Study Arms (2)

Group A - Prophylactic Timolol Maleate

EXPERIMENTAL

Participants received one drop of 0.5% timolol maleate ophthalmic solution immediately before Nd:YAG laser posterior capsulotomy. Intraocular pressure was measured before the procedure and 1 hour after capsulotomy. Participants also received the routine postoperative treatment prescribed for both study groups.

Drug: Timolol Maleate

Group B - Standard Care Alone

PLACEBO COMPARATOR

Participants underwent Nd:YAG laser posterior capsulotomy without receiving prophylactic timolol maleate. Intraocular pressure was measured before the procedure and 1 hour after capsulotomy. Participants received the same routine postoperative treatment as the experimental group.

Drug: No intervention

Interventions

Timolol Maleate DRUG

One drop of 0.5% timolol maleate ophthalmic solution was administered topically immediately before Nd:YAG laser posterior capsulotomy.

Group A - Prophylactic Timolol Maleate

No intervention DRUG

No prophylactic intraocular pressure-lowering medication was administered before Nd:YAG laser posterior capsulotomy.

Group B - Standard Care Alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• Male or female participants
• Diagnosed with posterior capsule opacification after cataract surgery
• Posterior capsule opacification present for at least 3 months
• Scheduled to undergo Nd:YAG laser posterior capsulotomy

You may not qualify if:

• History or documented diagnosis of glaucoma
• Baseline intraocular pressure greater than 21 mmHg before the procedure

Sponsors & Collaborators

• CMH Multan Institute of Medical Sciences: lead

Study Sites (1)

CMH Institute of Medical Sciences

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Capsule Opacification; Ocular Hypertension

Interventions

Timolol

Condition Hierarchy (Ancestors)

Cataract; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Ifrah Idress Lodhi

  CMH Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: March 10, 2025
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

PA (1)