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Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos

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ClinicalTrials.gov Identifier: NCT01818037
Recruitment Status : Completed
First Posted : March 26, 2013
Last Update Posted : March 26, 2013
Sponsor:
Information provided by (Responsible Party):
Abhay R. Vasavada, Iladevi Cataract and IOL Research Center

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment
Microphthalmos With Congenital Cataracts Procedure: Cataract surgery

Study Design
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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
Study Start Date : January 2003
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort Intervention/treatment
Microphthalmos with congenital cataract
72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.
 Procedure: Cataract surgery


Outcome Measures
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Primary Outcome Measures :
  1. Glaucoma following cataract surgery [ Time Frame: 45 months postoperative ]

Secondary Outcome Measures :
  1. Posterior synechiae [ Time Frame: 45 months postoperatively ]
  2. visual axis obscuration [ Time Frame: 45 months ]
  3. axial length rate of growth [ Time Frame: 45 months postoperatively ]
  4. central corneal thickness [ Time Frame: 45 months postoperatively ]
  5. visual acuity [ Time Frame: 45 months postoperatively ]

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818037


Locations
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India
Iladevi Cataract & IOL Research Center
Ahmedabad, Gujarat, India, 380052
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
More Information
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Responsible Party: Abhay R. Vasavada, Director, Iladevi Cataract and IOL Research Center, Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier: NCT01818037    
Other Study ID Numbers: 13-002
First Posted: March 26, 2013    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Cataract
Microphthalmos
Lens Diseases
 Eye Diseases
Eye Abnormalities
Congenital Abnormalities