Microphthalmos With Congenital CataractsNCT01818037
Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
An observational study of Microphthalmos With Congenital Cataracts, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding. In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus, glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of cataract surgery. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Microphthalmos With Congenital Cataracts
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2003to Mar 2013
- Phase
- Observational
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: 72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.
Who may be able to join
- Presence of microphthalmos and congenital cataract.
- Microphthalmos was defined as an eye with an axial length (AL) that is more than 2 SD smaller than the normal for that age group according to Gordon and Donzes
Who cannot join
- Children with congenital anomalies such as posterior persistent fetal vasculature causing stretching of the ciliary processes or a tractional retinal detachment, aniridia, and chorioretinal coloboma were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.
In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus, glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of cataract surgery.
Read more
In our previous study, the investigators examined the intraoperative performance and postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients before their first birthday. At 1 year, the postoperative results showed that good visual outcomes could be obtained in microphthalmic eyes.
Since only a few studies have reported outcomes, and that too only short term of cataract surgery on microphthalmic eyes, in this prospective observational study we evaluated the long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators examined the outcomes, complication rates, influence of age at surgery on pattern of axial growth and central corneal thickness and visual and orthoptic assessment in these eyes.
- Conditions
- Microphthalmos With Congenital Cataracts
- Being tested
- Cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Microphthalmos with congenital cataract | 72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008. Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glaucoma following cataract surgery
Measured: 45 months postoperative
Secondary outcomes (5)
Posterior synechiae
Measured: 45 months postoperatively
visual axis obscuration
Measured: 45 months
axial length rate of growth
Measured: 45 months postoperatively
central corneal thickness
Measured: 45 months postoperatively
visual acuity
Measured: 45 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startJan 2003
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microphthalmos With Congenital CataractsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhay R. Vasavada, Iladevi Cataract and IOL Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818037
- Sponsor's protocol ID
- 13-002
- Status last verified
- Mar 2013
- First submitted
- 21 Mar 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
- ClinicalTrials.gov ID
- NCT01818037
- Acronym / sponsor ID
- 13-002
- Conditions
- Microphthalmos With Congenital Cataracts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Mar 2013 (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.
Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.
In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus, glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of cataract surgery.
In our previous study, the investigators examined the intraoperative performance and postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients before their first birthday. At 1 year, the postoperative results showed that good visual outcomes could be obtained in microphthalmic eyes.
Since only a few studies have reported outcomes, and that too only short term of cataract surgery on microphthalmic eyes, in this prospective observational study we evaluated the long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators examined the outcomes, complication rates, influence of age at surgery on pattern of axial growth and central corneal thickness and visual and orthoptic assessment in these eyes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microphthalmos with congenital cataract | – | Procedure: Cataract surgery72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.
Key inclusion criteria (2 listed)
- Presence of microphthalmos and congenital cataract.
- Microphthalmos was defined as an eye with an axial length (AL) that is more than 2 SD smaller than the normal for that age group according to Gordon and Donzes
Key exclusion criteria (1 listed)
- Children with congenital anomalies such as posterior persistent fetal vasculature causing stretching of the ciliary processes or a tractional retinal detachment, aniridia, and chorioretinal coloboma were excluded.
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 |
|---|---|---|
| Cataract surgery | Procedure or surgery | Microphthalmos with congenital cataract |
Primary outcome
Glaucoma following cataract surgery
Time frame: 45 months postoperative
5 secondary outcomes
Posterior synechiae
Time frame: 45 months postoperatively
visual axis obscuration
Time frame: 45 months
axial length rate of growth
Time frame: 45 months postoperatively
central corneal thickness
Time frame: 45 months postoperatively
visual acuity
Time frame: 45 months postoperatively
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 26 Mar 2013.
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?
An observational study of Microphthalmos With Congenital Cataracts, run by Iladevi Cataract and IOL Research Center at 1 site in India.
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 2 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 26 Mar 2013. 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 India. 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?
Glaucoma following cataract surgery (time frame: 45 months postoperative). 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 26 Mar 2013.