Capsule OpacificationNCT07729189
Prophylactic Use of Timolol Maleate to Prevent Intraocular Pressure Elevation After Nd:YAG Laser Posterior Capsulotomy
A study testing Timolol Maleate in people with Capsule Opacification and Ocular Hypertension, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Capsule Opacification, Ocular Hypertension
- What is being tested?
- Timolol Maleate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History or documented diagnosis of glaucoma
- Baseline intraocular pressure greater than 21 mmHg before the procedure
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
CMH Institute of Medical Sciences
Multan, Punjab Province, 66000
About this study
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
- Being tested
- Timolol Maleate, No intervention
- Keywords
- Posterior Capsule Opacification, Timolol Maleate, Intraocular Pressure, Posterior Capsulotomy, Neodymium-Doped Yttrium Aluminum Garnet Laser
- Medical subject headings
- Capsule Opacification, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol MaleateDrug
One drop of 0.5% timolol maleate ophthalmic solution was administered topically immediately before Nd:YAG laser posterior capsulotomy.
No interventionDrug
No prophylactic intraocular pressure-lowering medication was administered before Nd:YAG laser posterior capsulotomy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after Nd:YAG laser posterior capsulotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start10 Mar 2025
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsule OpacificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Multan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sana Javed, CMH Multan Institute of Medical Sciences
- Investigators
- Ifrah Idress Lodhi, Principal investigator, CMH Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729189
- Sponsor's protocol ID
- CIMS2
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Timolol Maleate to Prevent Intraocular Pressure Elevation After Nd:YAG Laser Posterior Capsulotomy
- ClinicalTrials.gov ID
- NCT07729189
- Acronym / sponsor ID
- CIMS2
- Conditions
- Capsule Opacification, Ocular Hypertension
- Keywords
- Posterior Capsule Opacification, Timolol Maleate, Intraocular Pressure, Posterior Capsulotomy, Neodymium-Doped Yttrium Aluminum Garnet Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- CMH Multan Institute of Medical SciencesOther government
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Prophylactic Timolol Maleate | Experimental | Drug: Timolol MaleateParticipants 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. |
| Group B - Standard Care Alone | Placebo comparator | Drug: No interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- History or documented diagnosis of glaucoma
- Baseline intraocular pressure greater than 21 mmHg before the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timolol MaleateOne drop of 0.5% timolol maleate ophthalmic solution was administered topically immediately before Nd:YAG laser posterior capsulotomy. | Drug | Group A - Prophylactic Timolol Maleate |
| No interventionNo prophylactic intraocular pressure-lowering medication was administered before Nd:YAG laser posterior capsulotomy. | Drug | Group B - Standard Care Alone |
Primary outcome
Mean Intraocular Pressure 1 Hour After Nd:YAG Laser Posterior Capsulotomy
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ifrah Idress Lodhi principal investigator
CMH Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timolol Maleate in people with Capsule Opacification and Ocular Hypertension, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Intraocular Pressure 1 Hour After Nd:YAG Laser Posterior Capsulotomy (time frame: 1 hour after Nd:YAG laser posterior capsulotomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.