Intumescent CataractNCT07266844
CAPSULaser in Cases of Intumescent Cataract
A study testing CAPSULaser and capsulotomy in people with Intumescent Cataract, run by Zagazig University at 1 site in Saudi Arabia.
Trial summary
evaluating the use of selective laser in doing capsulotomy in intumescent cataract Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intumescent Cataract
- What is being tested?
- CAPSULaser and capsulotomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Jul 2025to 6 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with intumescent cataract and good pupil dilatation
Who cannot join
- absence of corneal scaring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Safety and Advantages of Using Selective Laser Capsulotomy to Create Capsulorhexis in Cases Intumescent Cataract
evaluating the use of selective laser in doing capsulotomy in intumescent cataract
Read the detailed description
Evaluating the safety and advantages of using selective laser capsulotomy for capsulorhexis creation in intumescent cataract
- Conditions
- Intumescent Cataract
- Being tested
- CAPSULaser, capsulotomy
- Keywords
- cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPSULaserProcedure or surgery
doing capsulotomy using CAPSULaser
capsulotomyDevice
capsulorhexis using CAPSULaser
| Study group | Role | What they receive |
|---|---|---|
| intumescent cataract | Other | CAPSULaser Receives: Procedure: CAPSULaser; Device: capsulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the actual size compared to result size as measured by slit lamp in mm
To measure the actual size compared to result size as measured by slit lamp
Measured: 3 months
Incidence and number of extended capsulorhexis to the total number of cases
Incidence and number of extended capsulorhexis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start8 Jul 2025
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intumescent CataractStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- intumescent cataract capsulorhexis
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266844
- Sponsor's protocol ID
- MEH-IRB# 432 - 7 - July -2025
- Other IDs
- Maghrabi eye hospitals
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Advantages of Using Selective Laser Capsulotomy to Create Capsulorhexis in Cases Intumescent Cataract
- ClinicalTrials.gov ID
- NCT07266844
- Acronym / sponsor ID
- MEH-IRB# 432 - 7 - July -2025
- Conditions
- Intumescent Cataract
- Keywords
- cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 5 Dec 2025 (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.
evaluating the use of selective laser in doing capsulotomy in intumescent cataract
Detailed description
Evaluating the safety and advantages of using selective laser capsulotomy for capsulorhexis creation in intumescent cataract
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- intumescent cataract capsulorhexis
| Arm | Type | Receives |
|---|---|---|
| intumescent cataract | Other | Procedure: CAPSULaser, Device: capsulotomyCAPSULaser |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with intumescent cataract and good pupil dilatation
Key exclusion criteria (1 listed)
- absence of corneal scaring
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 |
|---|---|---|
| CAPSULaserdoing capsulotomy using CAPSULaser | Procedure or surgery | intumescent cataract |
| capsulotomycapsulorhexis using CAPSULaser | Device | intumescent cataract |
Primary outcome
To measure the actual size compared to result size as measured by slit lamp in mm
Time frame: 3 months
To measure the actual size compared to result size as measured by slit lamp
Incidence and number of extended capsulorhexis to the total number of cases
Time frame: 1 month
Incidence and number of extended capsulorhexis
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 5 Dec 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPSULaser and capsulotomy in people with Intumescent Cataract, run by Zagazig University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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 5 Dec 2025. 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 Saudi Arabia. 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. 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?
To measure the actual size compared to result size as measured by slit lamp in mm (time frame: 3 months). The study lists 2 primary outcomes in all. 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 5 Dec 2025.