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OpenTrials
Completed

NCT Number: NCT01818037

Long-term Postoperative Outcomes 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.

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.

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Key information

Conditions

Microphthalmos With Congenital Cataracts

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Iladevi Cataract & IOL Research Center

Ahmedabad, Gujarat, 380052, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cataract surgery

Procedure

Primary outcomes

  1. Glaucoma following cataract surgery

    Time frame: 45 months postoperative

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2013
Registry last updated
Mar 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.