PterygiumNCT00563667
Effect of Pterygium Excision on Intraocular Lens Power Calculation for Subsequent Cataract Operation
A study testing pterygium excision in people with Pterygium and Cataract, run by Hospital Authority, Hong Kong at 3 sites in China.
Trial summary
Pterygium is known to induce with-the-rule astigmatism. Excision of pterygium will steepen the cornea and reduce corneal astigmatism. We postulate that the alteration of keratometry reading will indirectly affect the IOL power calculation in cases with concurrent pterygium and cataract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium, Cataract, Astigmatism
- What is being tested?
- pterygium excision
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2003to Dec 2004
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- All cases with concomitant cataract and primary pterygium, which are indicated for surgery.
Who cannot join
- Pterygium smaller than 1mm, which is not visually significant.
- Double headed pterygium
- Pterygium obscuring visual axis that preclude keratometry or autorefraction measurements.
- Previous corneal refractive surgery that alter the keratometric power of the cornea.
- Patients with medical problems that preclude staged ocular surgery, e.g. dementia, heart disease, on warfarin.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Alice Ho Miu Ling Nethersole Hospital
Hong Kong
Hong Kong Eye Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
About this study
Official title: Effect of Pterygium Excision on IOL Power Calculation: Concurrent Cataract and Pterygium
Pterygium is known to induce with-the-rule astigmatism. Excision of pterygium will steepen the cornea and reduce corneal astigmatism. We postulate that the alteration of keratometry reading will indirectly affect the IOL power calculation in cases with concurrent pterygium and cataract. Concurrent pterygium and cataract is common in Hong Kong and other tropical regions. The effect of pterygium excision on intraocular lens power calculation is investigated.
- Conditions
- Pterygium, Cataract, Astigmatism
- Being tested
- pterygium excision
- Keywords
- Pterygium, Cataract, Astigmatism
- Medical subject headings
- Pterygium, Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pterygium excisionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL power
Measured: 1 and 3 months post pterygium excision
Astigmatism
Measured: 1 and 3 months post pterygium excision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startDec 2003
- Study completionDec 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Lulu Cheng, Dr, Principal investigator, Department of DOVS, Prince of Wales Hospital/ The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563667
- Sponsor's protocol ID
- CRE-2003.353
- Other IDs
- HARECCTR0500013
- Status last verified
- Jul 2010
- First submitted
- 21 Nov 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pterygium Excision on IOL Power Calculation: Concurrent Cataract and Pterygium
- ClinicalTrials.gov ID
- NCT00563667
- Acronym / sponsor ID
- CRE-2003.353
- Conditions
- Pterygium, Cataract, Astigmatism
- Keywords
- Pterygium, Cataract, Astigmatism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Dec 2003
- Study completion
- Dec 2004 (estimated)
- First posted
- 26 Nov 2007 (estimated)
- 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.
Pterygium is known to induce with-the-rule astigmatism. Excision of pterygium will steepen the cornea and reduce corneal astigmatism. We postulate that the alteration of keratometry reading will indirectly affect the IOL power calculation in cases with concurrent pterygium and cataract. Concurrent pterygium and cataract is common in Hong Kong and other tropical regions. The effect of pterygium excision on intraocular lens power calculation is investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All cases with concomitant cataract and primary pterygium, which are indicated for surgery.
Key exclusion criteria (5 listed)
- Pterygium smaller than 1mm, which is not visually significant.
- Double headed pterygium
- Pterygium obscuring visual axis that preclude keratometry or autorefraction measurements.
- Previous corneal refractive surgery that alter the keratometric power of the cornea.
- Patients with medical problems that preclude staged ocular surgery, e.g. dementia, heart disease, on warfarin.
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 |
|---|---|---|
| pterygium excision | Procedure or surgery | – |
Primary outcome
IOL power
Time frame: 1 and 3 months post pterygium excision
Astigmatism
Time frame: 1 and 3 months post pterygium excision
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
Lulu Cheng, Dr principal investigator
Department of DOVS, Prince of Wales Hospital/ The Chinese University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pterygium excision in people with Pterygium and Cataract, run by Hospital Authority, Hong Kong at 3 sites in China.
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 5 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: status not confirmed, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Results are not available in the source record.
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?
IOL power (time frame: 1 and 3 months post pterygium excision). 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 7 Jul 2010.